Clinical trial · Observational
Luso-Cor Stent Compared to Other Endoscopic Techniques for Management of Fistulas and Anastomotic Dehiscences(ES-LCCE-UDFM)
Efficacy and Safety of the Luso-Cor Esophageal Stent Compared to Other Endoscopic Techniques in the Management of Fistulas and Anastomotic Dehiscences After Upper Digestive Tract Surgery (ES-LCCE-UDFM)
- 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)
The global prevalence of obesity has prompted an increase in bariatric surgery, which is the only management strategy that provides long-term weight loss and improvement of obesity-related diseases. Bariatric surgeries include sleeve gastrectomy(SG), Roux-en-Y gastric bypass(RYGB),and laparoscopically adjustable gastric banding(LAGB). The incidence of adverse events depends on the type of bariatric surgery performed, with serious adverse events occurring in approximately 4% and mortality in 0.1% patients. The incidence of fistulas after SG varies between 0.2% to 2.5% and between 1% and 4.9% in patients who have undergone an RYGB. The incidence of strictures after SG is approximately 0.35%. Older, more obese, and male patients with multiple comorbidities related to obesity are at increased risk for the development of fistulas and mortality following bariatric surgery. Additionally, surgery after LAGB increases the risk of adverse events. This study will compare the efficacy and safety of the Luso-Cor esophageal stent versus conventional covered metallic stents versus endoscopic vacuum therapy in the management of fistulas and anastomotic dehiscences after oncologic or bariatric surgery on the stomach and esophagus.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Anastomotic Leak Esophagus | — | UNRESOLVED | — |
| Dehiscence | — | UNRESOLVED | — |
| Dehiscence; Postoperative | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Fistula | — | UNRESOLVED | — |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic management of fistulas with stents or vacum therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fistulas after oncologic or bariatric surgery on the stomach or esophagus
- description
- Patients who develop fistulas after oncologic surgery on the stomach or esophagus or those patients who develop fistulas after bariatric surgery (Vertical or sleeve gastrectomy or gastric bypass) managed endoscopically with endoscopic vacuum therapy group.
- interventionNames
- Procedure: Endoscopic management of fistulas with stents or vacum therapy
Primary outcomes (2)
- measure
- Compare the efficacy of the Luso-Cor versus conventional stents versus endoscopic vacuum therapy in the management of fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery in terms of fistula closure.
- timeFrame
- 36 months for recruitment of 180 patients.
- description
- To evaluate and compare the performance of the Luso-Cor oesophageal stent with other stents or EVT in management of fistulas after bariatric and oncologic surgery on the upper digestive tract with regard to fistula closure rate expressed as percentage
- measure
- Compare the safety of the Luso-Cor versus conventional stents versus endoscopic vacuum therapy in the management of fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery in terms of rate of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing endoscopic management of fistulas after bariatric surgery or dehiscences of esophago-jejunal or gastro-jejunal anastomosis after esophageal or gastric oncologic surgery will be included in the study. Exclusion Criteria: * Pregnancy * Age \< 18years * Inability to give informed consent.
References
Publications (17)
- BACKGROUNDdo Monte Junior ES, de Moura DTH, Ribeiro IB, Hathorn KE, Farias GFA, Turiani CV, Medeiros FS, Bernardo WM, de Moura EGH. Endoscopic vacuum therapy versus endoscopic stenting for upper gastrointestinal transmural defects: Systematic review and meta-analysis. Dig Endosc. 2021 Sep;33(6):892-902. doi: 10.1111/den.13813. Epub 2020 Oct 28. PMID 33300634
- BACKGROUNDClinical Efficacy and Safety of a Novel Stent for Fistula Management Following Sleeve Gastrectomy Noronha Ferreira, Carlos et al. Techniques and Innovations in Gastrointestinal Endoscopy, Volume 26, Issue 1, 12 - 20
- BACKGROUNDEisendrath P, Cremer M, Himpens J, Cadiere GB, Le Moine O, Deviere J. Endotherapy including temporary stenting of fistulas of the upper gastrointestinal tract after laparoscopic bariatric surgery. Endoscopy. 2007 Jul;39(7):625-30. doi: 10.1055/s-2007-966533. PMID 17611917
- BACKGROUNDKanters AE, Shubeck SP, Varban OA, Dimick JB, Telem DA. Incidence and Efficacy of Stent Placement in Leak Management After Bariatric Surgery: An MBSAQIP Analysis. Ann Surg. 2020 Jan;271(1):134-139. doi: 10.1097/SLA.0000000000003023. PMID 30247333
- BACKGROUNDSwinnen J, Eisendrath P, Rigaux J, Kahegeshe L, Lemmers A, Le Moine O, Deviere J. Self-expandable metal stents for the treatment of benign upper GI leaks and perforations. Gastrointest Endosc. 2011 May;73(5):890-9. doi: 10.1016/j.gie.2010.12.019. PMID 21521563
- BACKGROUNDBege T, Emungania O, Vitton V, Ah-Soune P, Nocca D, Noel P, Bradjanian S, Berdah SV, Brunet C, Grimaud JC, Barthet M. An endoscopic strategy for management of anastomotic complications from bariatric surgery: a prospective study. Gastrointest Endosc. 2011 Feb;73(2):238-44. doi: 10.1016/j.gie.2010.10.010. PMID 21295637
- BACKGROUNDEubanks S, Edwards CA, Fearing NM, Ramaswamy A, de la Torre RA, Thaler KJ, Miedema BW, Scott JS. Use of endoscopic stents to treat anastomotic complications after bariatric surgery. J Am Coll Surg. 2008 May;206(5):935-8; discussion 938-9. doi: 10.1016/j.jamcollsurg.2008.02.016.