Clinical trial · Observational
Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy
Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy
NCT03962244CI-TRIAL-00051533EsoLeakunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leaks, Anastomotic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EsoSponge | Device | — | UNRESOLVED |
| Self-Expanding Metal Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SEMS Group
- description
- The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy
- interventionNames
- Device: Self-Expanding Metal Stent
- label
- EVT Group
- description
- The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy
- interventionNames
- Device: EsoSponge
Primary outcomes (1)
- measure
- Satisfaction of treatment assessed by EORTC QLQ - OES18
- timeFrame
- 6 months
- description
- Assessing the quality of life of patients during the treatment of stent and EVT with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed oesophageal carcinoma or similarly operated neoplasia (e.g., GIST, NET, subepithelial tumors) * Esophagectomy with an intrathoracic esophago-gastric anastomosis * Radiologically or endoscopically diagnosed esophago-gastric anastomotic leakage * Clinical symptoms / symptoms due to insufficiency or increase in signs of inflammation, most likely as a result of anastomotic leakage * Age ≥18 years * To empower the patient to understand the scope of the study and its consequences or information, to consent to it and to sign the educational documents. * Written declaration of consent of the patient to be included. If the patient is unable to sign by hand, a witness must confirm the oral examination by signature. Exclusion Criteria: * Macroscopically incompletely resected tumor (R2), palliative resection * Endoscopically verified necrosis or critical ischemia of the anastomotic region of the interponate * Size of insufficiency more than 50% of circumference * Impossibility of radiological interventional insertion of a drainage * Early anastomotic leak (≤ 48 hours postoperatively), late insufficiencies (\> 4 weeks) * Therapeutic anticoagulation * Severe septic shock that indicates surgical therapy * Pregnant and lactating women
References
Publications (7)
- RESULTBartella I, Mallmann C, Burger M, Toex U, Goeser T, Bruns C, Chon SH. Stent-over-sponge (SOS): a rescue option in patients with complex postoperative anastomotic leaks after esophagectomy. Endoscopy. 2019 Aug;51(8):E227-E228. doi: 10.1055/a-0885-9659. Epub 2019 May 2. No abstract available. PMID 31049889
- RESULTBerlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Holscher AH, Chon SH. Self-Expanding Metal Stents Versus Endoscopic Vacuum Therapy in Anastomotic Leak Treatment After Oncologic Gastroesophageal Surgery. J Gastrointest Surg. 2019 Jan;23(1):67-75. doi: 10.1007/s11605-018-4000-x. Epub 2018 Oct 29. PMID 30374816
- RESULTGrimminger PP, Goense L, Gockel I, Bergeat D, Bertheuil N, Chandramohan SM, Chen KN, Chon SH, Denis C, Goh KL, Gronnier C, Liu JF, Meunier B, Nafteux P, Pirchi ED, Schiesser M, Thieme R, Wu A, Wu PC, Buttar N, Chang AC. Diagnosis, assessment, and management of surgical complications following esophagectomy. Ann N Y Acad Sci. 2018 Dec;1434(1):254-273. doi: 10.1111/nyas.13920. Epub 2018 Jul 8. PMID 29984413
- RESULTChon SH, Toex U, Plum PS, Fuchs C, Kleinert R, Bruns C, Goeser T. Successful closure of a gastropulmonary fistula after esophagectomy using the Apollo Overstitch and endoscopic vacuum therapy. Endoscopy. 2018 Jul;50(7):E149-E150. doi: 10.1055/a-0592-6384. Epub 2018 Apr 13. No abstract available. PMID 29653446
- RESULTBludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Holscher AH, Schroder W, Chon SH. Results of endoscopic vacuum-assisted closure device for treatment of upper GI leaks. Surg Endosc. 2018 Apr;32(4):1906-1914. doi: 10.1007/s00464-017-5883-4. Epub 2017 Dec 7. PMID 29218673
- DERIVEDMandarino FV, Barchi A, Leone L, Fanti L, Azzolini F, Viale E, Esposito D, Salmeri N, Puccetti F, Barbieri L, Cossu A, Treppiedi E, Elmore U, Rosati R, Danese S. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023 Sep;37(9):7039-7050. doi: 10.1007/s00464-023-10213-8. Epub 2023 Jun 23.