healing occurs in most patients that receive endoscopic stents for anastomotic leakage; dislocation...

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ENDOSCOPY CORNER Healing Occurs in Most Patients That Receive Endoscopic Stents for Anastomotic Leakage; Dislocation Remains a Problem MARCUS FEITH,* SONJA GILLEN,* TIBOR SCHUSTER, JÖRG THEISEN,* HELMUT FRIESS,* and RALF GERTLER* *Department of Surgery, Institute of Medical Statistics and Epidemiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany BACKGROUND & AIMS: There is controversy about the best way to treat esophageal anastomotic leakage. We evaluated the effects of treatment with self-expanding metal stents in patients with esophageal anastomotic leakage after esophagec- tomy or gastrectomy for cancer. METHODS: We investigated outcomes and procedure-related complications of 115 patients who received endoscopic stents for anastomotic leakage after esophagectomy or gastrectomy at a university hospital from 2004 to 2009. We also performed a systematic literature review on stent therapy and compared outcomes with that of other treatment regimens for esophageal anastomotic leakage. RESULTS: Among the 115 patients who received stents, the in-hospital mortality rate was 9% and complete anastomotic healing was achieved in 70% (95% confidence interval [CI], 64%–76%). Stent dislocation occurred in 53% of the patients (95% CI, 43%– 62%), in all patients with esophagocolonostomy, in 61% with esophagoje- junostomy, and in 49% with esophagogastrostomy. Three percent of patients (95% CI, 1%–5%) needed laparotomy to remove dislo- cated stents. Elective endoscopic stent removal was performed in 80% of the patients after a median of 54 days (range 17– 427 d); 12% of these patients developed symptomatic anastomotic stric- tures after stent removal. CONCLUSIONS: Anastomoses completely heal in 70% of patients that receive endoscopic stents for anastomotic leakage after esophagectomy or gas- trectomy. Stent therapy should be used in the management of patients with adequately perfused esophageal anastomotic leakage. However, stent dislocation remains a common prob- lem after surgery. Keywords: Esophageal Cancer; Gastric Cancer; Cancer Therapy; Cancer Surgery. A nastomotic leakage after gastroesophageal resection for can- cer is reported to occur with an incidence between 2% and 40% and to be responsible for about 50% of postoperative mortal- ity. 1– 4 The most efficient treatment of anastomotic leakage after esophagectomy or gastrectomy, however, remains controversial. The spectrum of established therapeutic options range from reop- eration with discontinuity resection, diversion, or re-anastomosis to conservative treatment with perianastomotic drainage, paren- teral nutrition, naso-intestinal decompression, and broad-spec- trum antibiotics. Both surgical and conservative treatment op- tions, however, are associated with high mortality rates and extensively long intensive care unit and hospital stays. 1– 8 In the search for optimized management, the endoscopic placement of stents has been introduced in the management of anastomotic leakages in the past decade. Although the permanent endoscopic placement of self-expanding metal stents has long been established in the palliative treatment of esophagotracheal fistula and malig- nant obstruction in the upper gastrointestinal tract, 9,10 the re- moval of stents after temporary therapeutic use has not been reasonably possible until the emergence of completely covered stents. First reports on the use of covered stents in the manage- ment of postoperative esophageal anastomotic leakages are prom- ising, however, they are limited to very small case series in heter- ogeneous patient cohorts. 11–20 Moreover, complications of stent therapy for anastomotic leakage are mentioned rather anecdotally. The aim of this observational study was to describe our expe- rience in the use of covered self-expanding stents in the manage- ment of anastomotic leakage after resection for carcinoma of the esophagus or esophagogastric junction. We analyzed the outcome of stent therapy and report on stent-related complications. We also performed a literature review on stent therapy for esophageal anastomotic leakage and compared stent therapy with other con- servative and surgical treatment regimens. Patients and Methods Study Cohort Between 2003 and 2009, there were 1296 patients who underwent esophagectomy or trans-hiatally extended gastrectomy for carcinomas of the esophagus or esophagogastric junction in the Department of Surgery at the Klinikum Rechts der Isar, Tech- nische Universität München, as a national referral center for these tumor entities. In 115 patients (9%; 95% confidence interval [CI], 7.4%–10.5%), a fully covered self-expanding metal stent was placed endoscopically as the first treatment option for postoperative anastomotic leakage. These 115 patients comprise the study co- hort of this report. The median age was 61 years (range, 22– 88 y). Thirty-eight patients (33%) had squamous cell carcinomas of the esophagus and 77 patients (67%) had adenocarcinomas of the esophagus or esophagogastric junction. Surgery was performed after neoadjuvant chemotherapy or chemoradiotherapy in 89 pa- tients (77%). Stent therapy was performed in 28 patients (24%) after trans-hiatally extended gastrectomy with Roux-en-Y esoph- agojejunostomy, in 84 patients (73%) after esophagectomy and gastric tube pull-up, and in 3 patients (3%) after esophagectomy and colonic interposition (Table 1). All 115 leakages were located directly at the anastomosis of the remaining esophagus to the pulled-up jejunum (n 28), the pulled-up gastric tube (n 84), or the interposed colon (n 3). Abbreviations used in this paper: CI, confidence interval; CT, com- puted tomography. © 2011 by the AGA Institute 1542-3565/$36.00 doi:10.1016/j.cgh.2010.12.010 CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2011;9:202–210

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CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2011;9:202–210

ENDOSCOPY CORNER

Healing Occurs in Most Patients That Receive Endoscopic Stents forAnastomotic Leakage; Dislocation Remains a Problem

MARCUS FEITH,* SONJA GILLEN,* TIBOR SCHUSTER,‡ JÖRG THEISEN,* HELMUT FRIESS,* and RALF GERTLER*

*Department of Surgery, ‡Institute of Medical Statistics and Epidemiology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany

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BACKGROUND & AIMS: There is controversy about theest way to treat esophageal anastomotic leakage. We evaluatedhe effects of treatment with self-expanding metal stents inatients with esophageal anastomotic leakage after esophagec-omy or gastrectomy for cancer. METHODS: We investigatedutcomes and procedure-related complications of 115 patientsho received endoscopic stents for anastomotic leakage after

sophagectomy or gastrectomy at a university hospital from 2004o 2009. We also performed a systematic literature review on stentherapy and compared outcomes with that of other treatmentegimens for esophageal anastomotic leakage. RESULTS:

Among the 115 patients who received stents, the in-hospitalmortality rate was 9% and complete anastomotic healing wasachieved in 70% (95% confidence interval [CI], 64%–76%). Stentdislocation occurred in 53% of the patients (95% CI, 43%–62%), inall patients with esophagocolonostomy, in 61% with esophagoje-junostomy, and in 49% with esophagogastrostomy. Three percentof patients (95% CI, 1%–5%) needed laparotomy to remove dislo-cated stents. Elective endoscopic stent removal was performed in80% of the patients after a median of 54 days (range 17–427 d);12% of these patients developed symptomatic anastomotic stric-tures after stent removal. CONCLUSIONS: Anastomosescompletely heal in 70% of patients that receive endoscopicstents for anastomotic leakage after esophagectomy or gas-trectomy. Stent therapy should be used in the management ofpatients with adequately perfused esophageal anastomoticleakage. However, stent dislocation remains a common prob-lem after surgery.

Keywords: Esophageal Cancer; Gastric Cancer; Cancer Therapy;Cancer Surgery.

Anastomotic leakage after gastroesophageal resection for can-cer is reported to occur with an incidence between 2% and

0% and to be responsible for about 50% of postoperative mortal-ty.1–4 The most efficient treatment of anastomotic leakage aftersophagectomy or gastrectomy, however, remains controversial.he spectrum of established therapeutic options range from reop-ration with discontinuity resection, diversion, or re-anastomosiso conservative treatment with perianastomotic drainage, paren-eral nutrition, naso-intestinal decompression, and broad-spec-rum antibiotics. Both surgical and conservative treatment op-ions, however, are associated with high mortality rates andxtensively long intensive care unit and hospital stays.1–8 In the

search for optimized management, the endoscopic placement ofstents has been introduced in the management of anastomoticleakages in the past decade. Although the permanent endoscopic

placement of self-expanding metal stents has long been established

in the palliative treatment of esophagotracheal fistula and malig-nant obstruction in the upper gastrointestinal tract,9,10 the re-moval of stents after temporary therapeutic use has not beenreasonably possible until the emergence of completely coveredstents. First reports on the use of covered stents in the manage-ment of postoperative esophageal anastomotic leakages are prom-ising, however, they are limited to very small case series in heter-ogeneous patient cohorts.11–20 Moreover, complications of stentherapy for anastomotic leakage are mentioned rather anecdotally.

The aim of this observational study was to describe our expe-ience in the use of covered self-expanding stents in the manage-

ent of anastomotic leakage after resection for carcinoma of thesophagus or esophagogastric junction. We analyzed the outcomef stent therapy and report on stent-related complications. We alsoerformed a literature review on stent therapy for esophagealnastomotic leakage and compared stent therapy with other con-ervative and surgical treatment regimens.

Patients and MethodsStudy CohortBetween 2003 and 2009, there were 1296 patients who

underwent esophagectomy or trans-hiatally extended gastrectomyfor carcinomas of the esophagus or esophagogastric junction inthe Department of Surgery at the Klinikum Rechts der Isar, Tech-nische Universität München, as a national referral center for thesetumor entities. In 115 patients (9%; 95% confidence interval [CI],7.4%–10.5%), a fully covered self-expanding metal stent was placedendoscopically as the first treatment option for postoperativeanastomotic leakage. These 115 patients comprise the study co-hort of this report. The median age was 61 years (range, 22–88 y).Thirty-eight patients (33%) had squamous cell carcinomas of theesophagus and 77 patients (67%) had adenocarcinomas of theesophagus or esophagogastric junction. Surgery was performedafter neoadjuvant chemotherapy or chemoradiotherapy in 89 pa-tients (77%). Stent therapy was performed in 28 patients (24%)after trans-hiatally extended gastrectomy with Roux-en-Y esoph-agojejunostomy, in 84 patients (73%) after esophagectomy andgastric tube pull-up, and in 3 patients (3%) after esophagectomyand colonic interposition (Table 1). All 115 leakages were locateddirectly at the anastomosis of the remaining esophagus to thepulled-up jejunum (n � 28), the pulled-up gastric tube (n � 84),or the interposed colon (n � 3).

Abbreviations used in this paper: CI, confidence interval; CT, com-puted tomography.

© 2011 by the AGA Institute1542-3565/$36.00

doi:10.1016/j.cgh.2010.12.010

Table 1. Literature Review of 8 Case Series on Stent Therapy for Esophageal Leakage With at Least 10 Patients With Anastomotic Leakage After Esophagectomy orGastrectomy for Cancer

Roy-Choudhuryet al12

Doniecet al13

Schubertet al14

Langeret al15

Kaueret al16

Tuebergenet al17

Leerset al18

Daiet al19 Total

Patients, n 14 21 12 24 10 32 31 22 166Leakage OE � GEa/leakage

othersb/perforation, n14/0/0 18/1/2 11/1/0 21/3/0 10/0/0 22/2/8 15/2/14 22/0/0 133/9/24

Stent type Multiplec Ultraflex Polyflex Polyflex Choo Multipled Ultraflex PolyflexMedian time to diagnosis, d (range) 13.5 (3–28) 6 (3–15) 6 (3–12) n.r. n.r. n.r.e,f n.r. 6.5 (1–13)Median time to stenting, d (range) 19.5 (9–34) 6 (3–15) 6 (3–12) 19 (4–65) n.r. 14 (0–611) n.r.g n.r.h

Complication of stent placement 0% (0/14) 0% (0/21) 0% (0/12) 8%i (2/24) 0% (0/10) 0% (0/32) 0% (0/31) 0% (0/22) 1% (2/166)Primary sealing of leakage 100% (14/14) 90% (19/21) 100% (12/12) 80%j (16/20) 90% (9/10) 78% (25/32) 84% (26/31) 95% (21/22) 88% (142/162)Healing of leakage 93%k (13/14) 81% (17/21) 92% (11/12) n.r. 70% (7/10) 78% (25/32) n.r. 95% (21/22) 85% (94/111)Re-operations 0% (0/14) 0% (0/21) 0% (0/12) 13% (3/24) 0% (0/10) 25% (8/32) 6% (2/31) 9% (2/22) 9% (15/166)In-hospital mortality 7% (1/14) 29% (6/21) 0% (0/12) 25% (6/24) 20% (2/10) 16% (5/32) 6% (2/31) 5% (1/22) 14% (23/166)Patients with stent dislocation n.r.l 5% (1/21) 17% (2/12) 29% (7/24) 40% (4/10) 6% (2/32) 3% (1/31) 23% (5/22) 14% (22/152)Elective stent removal No Yes Yes Nom/yesn Yes Yes Yes Yes

NOTE. Ultraflex (Boston Scientific, Natick, MA); Gianturco Rosch Z (Cook, Bjaeverskov, Denmark); Polyflex (Rüsch, Kernen, Germany); and Telestep Wallstent (Schneider, Minneapolis, MN).n.r, not reported.aLeakage after esophagectomy or gastrectomy for cancer.bLeakage after other surgeries.cUltraflex, Gianturco Rosch Z, Telestep Wallstent.dUltraflex, Choo, Flex-stent.eTime from surgery to diagnosis was 10 days (range, 2–49 d).fTime from perforation to diagnosis 4 days (range, 0–24 d).gStent placement was performed within the first 24 hours of diagnosis in 14 of 31 patients (45%).hTime from diagnosis to stenting was 2.7 days (0–14 d).iIn 2 of 24 patients, initial stent misplacement led to enlargement of leakage.jSixteen of 18 patients, 4 patients not evaluable with contrast swallow.kWith stent in place, not confirmed by contrast swallow in all patients.lNineteen stents placed in 14 patients.mNot recommended after esophagectomy.nRecommended after gastrectomy.

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204 FEITH ET AL CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 9, No. 3

Diagnosis and Management of AnastomoticLeakageOur diagnostic and therapeutic management of esoph-

ageal anastomotic leakage is outlined in Figure 1. Anastomotichealing was monitored primarily by clinical means. Only in caseof clinical suspicion of anastomotic leakage did the patient

Figure 1. Diagnostic and therapeutic managem

undergo flexible upper endoscopy. If endoscopy revealed a com-plete ischemia or necrosis of the anastomosed jejunum, gastricconduit, or interposed colon, the patient immediately under-went re-operation with discontinuity resection of the primaryreconstruction. Stent therapy was performed only in patientswith adequate perfusion of the anastomotic region.

ent of esophageal anastomotic leakage.

hoo s

March 2011 STENT THERAPY FOR ESOPHAGEAL ANASTOMOTIC LEAK 205

For stent therapy, 1 of 2 types of fully covered self-expandingmetal stents was placed by an experienced interventional en-doscopist: a Choo stent (diameter shaft, 18 mm; diameterproximal throat, 24 mm; M.I. Tech, Seoul, Korea) (Figure 2A) in109 patients or, since 2006, a Niti-S stent (diameter shaft, 20mm; diameter proximal throat, 28 mm; Taewoong Medical,Seoul, Korea) (Figure 2B) in 6 patients. The design of bothstents includes a retrieval lasso at both ends for removal andadjustment of the stent. For endoscopic stent placement, allpatients received intravenous sedation with midazolam 2 to 10mg combined with diisopropylphenol 20 to 200 mg. No patientrequired general anesthesia with intubation for the endoscopicprocedure. After the leakage was identified endoscopically andmarked by a radiopaque marker, the stent was placed tran-sorally with a guidewire. Per our normal routine, the stent waschecked by contrast swallow 1 day later to allow for completeexpansion of the stent. If complete sealing of the leakage wasachieved, enteral feeding was started orally with soft food instable patients or through enteral probes in intensive carepatients (Figure 3).

Endoscopic stent therapy was always accompanied by assess-ment of the perianastomotic region by computed tomography(CT) scan. If the intraoperatively placed drain had been re-moved already, or if the CT scan revealed inadequate drainageof the perianastomotic region by the intraoperatively placeddrain, additional chest tubes or pigtail drains were insertedunder CT guidance to completely drain all visible fluid collec-tions in all patients. Concomitantly, all patients also receivedbroad-spectrum antibiotic therapy.

In the case of a clinically uneventful postinterventionalcourse, no intermediate controls were performed; in fact, thestent was removed endoscopically 4 to 6 weeks later. Again,

Figure 2. (A) Example of a used, fully covered C

stent removal was performed under intravenous sedation with

midazolam and diisopropylphenol using a single-channel en-doscope. With a forceps, the proximal retrieval lasso wasgrasped and the stent was pulled out. Complete healing of theleakage was assessed by endoscopy, and a post–stent-extractioncontrast swallow. In patients with residual leakage after routinestent removal, a new stent was placed or an alternative endo-scopic therapy such as application of fibrin glue or hemostaticclips was used. In the case of clinical signs of persistent leakagein the postinterventional course, repeated endoscopies, contrastswallows, or CT scans were performed immediately on-demandand further interventions were performed as necessary.

MethodsClinical data of patients with esophageal and gastric

cancer were entered prospectively in our gastroesophageal da-tabase. Assuming that all stents were positioned correctly atinitial stent placement, any kind of incorrect stent position inthe further course was defined as stent dislocation. Becausestent dislocations were encountered at different time points, wedistinguished early, intermediate, and late dislocations. Incom-plete sealing of the leakage at routine contrast swallow 1 dayafter stent placement was assumed to be caused by (minor)stent dislocation and was classified as early dislocation. Inter-mediate stent dislocations occurred after routine postinterven-tional contrast swallow and before complete healing of theleakage. Early and intermediate stent dislocations with persis-tent leakage required re-endoscopy with stent repositioning orstent removal with placement of a new stent. Late stent dislo-cations occurred after complete healing of the leakage and thusrequired no re-stenting.

We analyzed our clinical database and the medical files of115 consecutive patients with stent therapy. In addition, we

tent. (B) Example of a fully covered Niti-S Stent.

performed a systematic literature review on the management of

206 FEITH ET AL CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 9, No. 3

esophageal anastomotic leakage with endoscopic stent place-ment. To minimize the heterogeneity of the patient cohorts ofthe available studies, only studies that comprised at least 10patients undergoing stent therapy after esophagectomy or gas-trectomy for cancer were included.

ResultsThe median interval between surgery and diagnosis of

anastomotic leakage with endoscopic stent placement was 8days (range, 3–21 d).

Outcome of Stent TherapyStent placement was technically feasible in all 115 pa-

tients without procedure-related morbidity or mortality. Rou-tine contrast swallow 1 day after stent placement was impossi-ble in 21 of 115 patients (18%) because of their septic status. Inthe remaining 94 patients, contrast swallow showed completesealing of the leakage in 70 patients (74%) and persistent leak-age in 24 patients (26%). All patients with incomplete sealing of

Figure 3. (A) Endoscopic view of anastomotic leakage in an esophaself-expanding metal stent. (C) Contrast swallow of anastomotic leakagthe anastomotic leakage and drainage with a chest tube.

the leakage underwent re-endoscopy with repositioning of the

stent, stent extraction and placement of a new stent, or place-ment of an additional second stent overlapping the first stent.

Complete healing of the leakage as diagnosed by endoscopyand contrast swallow after stent removal 4 to 6 weeks after stentplacement was achieved in 80 of 115 patients (70%; 95% CI,64%–76%). This was achieved after placement of 1 stent in 59 of115 patients (51%), 2 stents in 16 of 43 patients (37%), and afterplacement of 3 or more stents in 5 of 20 patients (25%) (range,3–10 stents). Thus, the rate of healing decreased with increasingnumbers of stents applied. Anastomotic healing was indepen-dent of the type of stent.

In 35 of 115 patients (30%; 95% CI, 23%–37%), stent therapydid not result in complete healing of the leakage. However, suchcomplete healing finally could be achieved in 9 patients (8%) byadditional endoscopic application of fibrin glue or hemostaticclips for asymptomatic persisting minor anastomotic leakageafter routine stent removal. In another 4 patients (3%), stenttherapy also did not result in complete healing but induced theformation of a stable, almost asymptomatic, fistula with which

unostomy. (B) Coverage of the anastomotic leakage with a coveredn esophagojejunostomy. (D) Contrast swallow after stent placement of

gojeje of a

the patients could be discharged from the hospital. Twelve

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March 2011 STENT THERAPY FOR ESOPHAGEAL ANASTOMOTIC LEAK 207

patients (10%) with progressive septic symptoms during stenttherapy underwent reoperation, the anastomosis disconnected,and the primary reconstruction was removed. Only 2 of them(2%) underwent reconstruction secondarily with colonic inter-position after clinical stabilization. Of the remaining 10 pa-tients undergoing reoperation, 2 (2%) died in the postoperativecourse, 5 (4%) died of tumor progress after discharge from thehospital, and 3 (3%) are still alive but not in condition forfurther reconstructive surgery. Finally, another 8 patients (7%)who did not undergo reoperation died in the course of stenttherapy during their primary hospital stay with 5 of them (4%)showing perpetuating septic course, 2 of them (2%) dying ofacute cardiac failure, and 1 patient (1%) dying of fulminantpulmonary embolism resulting from a deep venous thrombosis.Overall, the in-hospital mortality rate was 9% (10 of 115 pa-tients).

Complications of Stent TherapyStent perforation was seen in 1 of 115 patients (1%). In

this case, the stent, which was correctly placed over a leakingesophagogastrostomy, perforated through the pulled-up gastrictube into the trachea. We performed immediate re-thoracotomywith resection of the gastric tube and closure of the trachealfistula using a muscle flap.

The most frequent complication of stent therapy was stentdislocation and occurred in 61 of 115 patients (53%), including41 of 84 patients (49%) with esophagogastrostomy, 17 of 28patients (61%) with esophagojejunostomy, and all 3 patients(100%) with esophagocolonostomy. Although 60 of 109 pa-tients (55%) who primarily were stented with a Choo stent hada stent dislocation, the rate of stent dislocation for the Niti-Sstent was 1 of 6 patients (17%). Early, intermediate, and latestent dislocations were encountered in 24, 28, and 17 of 115patients (21%, 24%, and 15%), respectively. Early and interme-diate stent dislocation with persistent leakage led to repeatedstent placements in 43 patients. Overall, 72 patients (63%)received 1 stent, 23 patients (20%) received 2 stents, 9 patients(8%) received 3 stents, and 11 patients (10%) received more than3 stents (range, 4 –10 stents). Patients with late stent dislocation

Figure 4. Abdominal radiograph showing a dislocated stent stuck athe Roux-en-Y anastomosis in a patient after gastrectomy.

presented in 3 different ways. First, in 6 of 115 patients (5%), the

stent dislocated completely, migrated asymptomatically th-rough the entire intestinum, and was harvested from the pa-tient’s excretion by chance. Second, the stent was not in place atroutine endoscopy 4 to 6 weeks after stent placement and wasnot detectable by other means such as radiographs in 7 of 115patients (6%). Thus, unrecognized complete intestinal passagemust have been assumed as well. Third, surgical interventionswere necessary in 4 of 115 patients (3%), all owing to late stentdislocations. In 3 of these patients, all stented for leakingesophagojejunostomy, the stent also was not detectable at rou-tine endoscopy 4 to 6 weeks after stent placement, but wasfound on abdominal radiographs in the small intestine notreachable by endoscopy. Because all 3 patients were completelyasymptomatic, we made no further effort to remove the stent atthat time and waited for completion of the intestinal passage.However, all 3 patients presented with acute abdomen 3months, 2 months, and 1 week later (Figure 4) and underwentemergency laparotomy. The stents were stuck at the Roux-en-Yanastomosis in 2 patients and at the ileocecal valve in 1 patient,causing intestinal perforations at these sites. We performedresection of the affected part of the intestine in all 3 patients(Figure 5). In the remaining patient undergoing surgical inter-vention, we performed prophylactic open gastrotomy to removea dislocated stent before the onset of symptoms because thisstent had asymptomatically migrated into the stomach butcould not be removed endoscopically because of a stricture ofthe esophagogastrostomy.

Endoscopic Follow-Up EvaluationOf the 95 surviving patients who were stented and did

not undergo reoperation, 93 patients (98%) were followed up inour department for at least 3 months after initial surgery witha mean follow-up period of 17 months (range, 3–73 mo). En-doscopic stent removal was performed in 74 of 93 patients(80%) after a median of 54 days (range, 17– 427 d) after initialstent placement. In 5 of these patients (5%), the retrieval lassocould not be grasped as a result of tissue ingrowth. In thesecases, the proximal end of the stent itself was mobilizedendoscopically and directly grasped with a forceps to removethe stent. In 2 more patients (2%), the stent was not remov-able at all because of hyperplastic tissue overgrowth. Thewhereabouts of the stents in the remaining 17 patients al-ready have been exemplified earlier with surgical removal in

Figure 5. Resection specimen of a dislocated stent that got stuck and

caused intestinal perforation at the ileocecal valve.

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208 FEITH ET AL CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 9, No. 3

4 patients (4%) and asymptomatic complete intestinal pas-sage in 13 patients (14%). Eleven patients (12%) developedsymptomatic anastomotic strictures and all were treated en-doscopically by bougie dilations. Endoscopy revealed anas-tomotic stricture in another 24 patients (26%) who, however,were clinically asymptomatic. In these patients, we per-formed prophylactic bougie dilations.

Literature ReviewQuantitative analysis of our literature review with all

available studies on stent therapy that comprised 10 or morepatients with esophageal anastomotic leakage after esophagec-tomy or gastrectomy for cancer is shown in Table 1.

DiscussionThe concept of additional stent placement in the con-

servative management of esophageal anastomotic leakage afteresophagectomy or gastrectomy provides the advantage of im-mediate leak occlusion, which allows early oral feeding, avoidsfurther contamination of the mediastinum, and, finally, resultsin shorter hospital stays.12–19 However, stent placement alsoforces the need for adequate perianastomotic drainage becausestents not only stop further intestinal leakage to the extraint-estinal perianastomotic region but also prevent internal drain-age of any fluid collection in the mediastinum or pleural cavi-ties.

These issues have been emphasized repeatedly in severalreports, however, without finally rendering endoscopic stenttherapy the treatment of choice for anastomotic esophagealleakage.12–19 This is mainly owing to fundamental deficits of the

vailable studies, among them small case loads (all �32 pa-ients),12–19 different underlying diseases (malignant and be-

nign),14,15,17 heterogeneous causes of esophageal leaks (anasto-otic leakages and esophageal perforations),13–15,17,18 and

varying therapeutic regimens with different time intervals be-tween diagnosis and treatment (stent therapy as first treatmentoption, after ineffective other therapeutic means, or even aslast-choice procedure).15,17 In the present study, we only in-luded patients with esophageal anastomotic leakages aftersophagectomy or gastrectomy for cancer that primarily wereanaged with stent placement right after diagnosis of the

eakage. Our series of 115 patients is a large cohort. However,imilar to all other studies, ours also was not randomized andherefore lacked a control group.

Thus, comparison of stent therapy with other treatmentegimens can be made only by looking into published figures.or surgical revision and for conservative treatment withoutstent, in-hospital mortality rates are reported at 35% to

4%1– 4 and 19% to 46%,4,6 – 8,21,22 respectively. Compared withhese numbers, the in-hospital mortality in our series (9%)nd in other reports on stent therapy (0%–29%)12–19 is sub-tantially lower. With respect to healing of the esophagealeakage, numbers are given at 59%22 and 58%21 for conserva-ive treatment without a stent but at 70% to 95% with stentherapy.12–19 It must be mentioned, however, that compari-

sons of stent therapy with other treatment regimen foresophageal leakages are limited by the heterogeneous natureof the patient cohorts. Because there is common agreementin the literature that extensive ischemia of the conduit is not

an indication for stent therapy but necessitates immediate p

reoperation, these assumingly most severe cases consistentlyare excluded from the stent group and find themselves un-exceptionally in the surgical revision group. Apart from that,the criteria qualifying for stent therapy, if at all clearlydefined, differ considerably between studies. Although westented all adequately perfused anastomotic leakages irre-spective of size, some investigators restrict stent therapyto leakages affecting less than one third,15 less thanwo thirds,17 or less than 70% of the circumference,14 and

some also set a minimum size of the leakage for stenttherapy.12–14,16 We believe that the state of perfusion of the

nastomotic region is the paramount determinant for heal-ng, and that therefore endoscopy is the decisive diagnosticool and that all adequately perfused esophageal anasto-

otic leakages qualify for stent therapy. Nevertheless, theize of the leakage, the time from appearance of leakage toiagnosis and treatment, and the degree of mediastinal orleural infection are important parameters that influence theutcome of stent therapy. With these parameters in mind, itppears highly plausible that the most favorable outcomes oftent therapies have been reported for iatrogenic esophagealerforation.5,23 To mimic this ideal situation in the postop-

erative course, we strongly recommend immediate endoscopyon the slightest clinical suspicion of anastomotic leakageand stent placement without the least delay to keep extra-esophageal infection as minimal as possible.

The outcome of stent therapy presented in this study andpublished elsewhere is convincing because the mainly technicalconcerns on temporary stent placement appear unwarranted.The available data show that stent placement was technicallyfeasible in virtually all patients without procedure-related mor-bidity or mortality and led to instant primary sealing of theleakage in 74% of our patients and in 88% (range, 78%–100%) ofthe patients in other studies.12–19 Moreover, elective stent re-moval proved to be endoscopically feasible in the vast majorityof patients and most investigators, including us, explicitly rec-ommend elective stent removal to avoid possible complicationsof permanent stenting such as penetration, dislocation, steno-sis, and reflux with aspiration.13,14,16 –19 Finally, all anastomoticstrictures after stent removal in our series and most otherreports could be handled endoscopically.13,15

Nevertheless, there can be no denying that a couple ofstent-specific problems may occur. The rate of patients withstent dislocation was remarkably high at 53% in our series.Interestingly, we saw stent dislocation in all patients withesophagocolonostomies. The numbers for esophagojejunos-tomies and esophagogastrostomies in our series were 61%and 49%, respectively. Langer et al15 had similar results foresophagocolonostomies (100%) and esophagogastrostomies(44%) but encountered stent dislocation in only 1 of 5 pa-tients with esophagojejunostomies (20%). It is important tomention that stent dislocation is observed more frequentlyin the therapy of anastomotic leakage than in the palliativetreatment of malignant stenosis in which rigid tumor steno-sis provides an outer force on the stent for a tight fit andreduced risk of dislocation.24 In this context, our observation

f less stent dislocations with the Niti-S stent also could bettributed to its larger diameter, possibly resulting in aighter fit to the esophageal wall. However, numbers are toomall to draw conclusions on stent sizes from our study. In

arallel, the different rates of stent dislocation encountered

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March 2011 STENT THERAPY FOR ESOPHAGEAL ANASTOMOTIC LEAK 209

for the different types of anastomoses also might be causedby differences in the anatomic texture and motility of theanastomosed colon, stomach, and small intestine. Althoughall early and intermediate stent dislocations could be man-aged endoscopically, both complete intestinal passage andsurgical stent removals were seen only in late stent disloca-tions. This most likely is owing to early diagnosis in patientswith early or intermediate stent dislocation because theybecome symptomatic for persisting leakage before the stentvanishes out of endoscopic range. In these patients, evenrepeated endoscopic interventions appear worthwhile,15 al-beit the rate of healing decreased with the number of stentsapplied in our series. Stent dislocation with intestinal ob-struction and subsequent intestinal perforation, however, isa major complication requiring surgery. However, cases ofbowel perforation caused by stent migration rarely are re-ported in the literature but appear to be associated mostlywith small-bowel obstruction.25–27 We assume that the rate ofpatients requiring surgical intervention for removal of dis-located stents is still underestimated in the literature becausemost reports on stent dislocations are from nonsurgicalpatients. It appears plausible that the risk for stents to getstuck somewhere in the intestine is higher in patients whounderwent extended abdominal surgeries with altered intra-abdominal anatomy and, most likely, adhesions than innonoperated patients with a high chance of asymptomaticcomplete intestinal passage. Surgical revision clearly is re-quired in patients with intestinal perforation. However,based on our experience, we also suggest early surgical inter-vention in the case of endoscopically unreachable stent dis-location in patients undergoing surgery for upper gastroin-testinal carcinomas.

In summary, the available data clearly show the feasibilityof temporary stent placement and removal with low proce-dure-related morbidity and mortality and, because of thefavorable outcome of stent therapy compared with othertreatment regimens, suggest stent therapy as the treatmentof choice in the management of adequately perfused esoph-ageal anastomotic leakage. However, because stent disloca-tion remains a common problem in these postoperative pa-tients, the optimal type of stent, the best time for stentremoval, and useful additional endoscopic means for stentfixation have yet to be defined in these patients.25,26 On thisbasis, it can be concluded that an experienced interventionalendoscopist is indispensable for any surgical unit performingesophageal surgery.

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Reprint requestsAddress requests for reprints to: Prof. Marcus Feith, MD, Chirurgis-

che Klinik und Poliklinik, Klinikum Rechts der Isar, Technische Univer-sität München, Ismaningerstr 22, 81675 Munich, Germany. e-mail:

[email protected]; fax: �49 89 4140 4870.

Conflicts of interest

The authors disclose no conflicts.