Luso-Cor Stent Compared to Other Endoscopic Techniques for Management of Fistulas and Anastomotic Dehiscences(ES-LCCE-UDFM)

NCT06862479 | Enrolling By Invitation

• 1 other identifier: 001
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obesity; Obesity, Morbid; Esophageal Cancer; Esophageal Neoplasms; Gastric Cancer; Gastric Adenocarcinoma; Fistula; Dehiscence; Anastomotic Leak; Anastomotic Leak Esophagus; Dehiscence; Postoperative

Keywords

Fistulas; Anastomotic dehiscences; Endoscopic management; Stents; Endoscopic vacuum therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  36 months for recruitment of 180 patients.

• 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

  To evaluate and compare the safety 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 early and late adverse event rate expressed as percentage.

  36 months for recruitment of 180 patients.

Secondary Outcomes (4)

• Compare the technical success 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

  36 months for recruitment of 180 patients.

• Compare duration of hospitalization in patients developing fistulas after oncologic surgery on the stomach and esophagus or bariatric surgery managed with the Luso-Cor versus conventional stents versus endoscopic vacuum therapy.

  36 months for recruitment of 180 patients.

• Compare the number of endoscopies till fistula closure in patients managed with the Luso-Cor versus conventional stents versus endoscopic vacuum therapy who developed fistulas after oncologic surgery on the stomach and esophagus or bariatric surgery.

  36 months for recruitment of 180 patients.

• Compare the mortality in patients who developed fistulas after oncologic surgery on the stomach and esophagus and bariatric surgery, managed with the Luso-Cor versus conventional stents versus endoscopic vacuum therapy.

  36 months for recruitment of 180 patients.

Study Arms (1)

Fistulas after oncologic or bariatric surgery on the stomach or esophagus

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.

Procedure: Endoscopic management of fistulas with stents or vacum therapy

Interventions

Endoscopic management of fistulas with stents or vacum therapy PROCEDURE

A prospective registry of patients who develop fistulas after oncologic surgery on the stomach or esophagus as well as those after bariatric surgery and managed endoscopically with stents or endoscopic vacuum therapy will be evaluated to assess and compare the efficacy and safety of the Luso-Cor versus conventional partially or fully covered metallic stents or bariatric stents or endoscopic vacuum therapy.

Fistulas after oncologic or bariatric surgery on the stomach or esophagus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who develop fistulas or anastomotic dehiscences after oncologic surgery on the stomach or esophagus or after bariatric surgery.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Age \< 18years
• Inability to give informed consent.

Sponsors & Collaborators

• Unidade Local de Saúde Santa Maria: lead

Study Sites (1)

Serviço de Gastrenterologia e Hepatologia, Unidade Local de Saúde Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

Location

Related Publications (17)

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  PMID: 33300634 BACKGROUND

• Clinical 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

  BACKGROUND

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• Bege 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.

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  PMID: 26699374 BACKGROUND

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  PMID: 18392906 BACKGROUND

• Rosenthal RJ; International Sleeve Gastrectomy Expert Panel; Diaz AA, Arvidsson D, Baker RS, Basso N, Bellanger D, Boza C, El Mourad H, France M, Gagner M, Galvao-Neto M, Higa KD, Himpens J, Hutchinson CM, Jacobs M, Jorgensen JO, Jossart G, Lakdawala M, Nguyen NT, Nocca D, Prager G, Pomp A, Ramos AC, Rosenthal RJ, Shah S, Vix M, Wittgrove A, Zundel N. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012 Jan-Feb;8(1):8-19. doi: 10.1016/j.soard.2011.10.019. Epub 2011 Nov 10.

  PMID: 22248433 BACKGROUND

• Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54. doi: 10.1056/NEJMoa0901836.

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• American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. American Society for Metabolic and Bariatric Surgery position statement on global bariatric healthcare. Surg Obes Relat Dis. 2011 Nov-Dec;7(6):669-71. doi: 10.1016/j.soard.2011.08.009. Epub 2011 Aug 27. No abstract available.

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• Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.

  PMID: 15616203 BACKGROUND

• Schiesser M, Kressig P, Bueter M, Nocito A, Bauerfeind P, Gubler C. Successful endoscopic management of gastrointestinal leakages after laparoscopic Roux-en-Y gastric bypass surgery. Dig Surg. 2014;31(1):67-70. doi: 10.1159/000358849. Epub 2014 May 8.

  PMID: 24819500 BACKGROUND

• Rogalski P, Swidnicka-Siergiejko A, Wasielica-Berger J, Zienkiewicz D, Wieckowska B, Wroblewski E, Baniukiewicz A, Rogalska-Plonska M, Siergiejko G, Dabrowski A, Daniluk J. Endoscopic management of leaks and fistulas after bariatric surgery: a systematic review and meta-analysis. Surg Endosc. 2021 Mar;35(3):1067-1087. doi: 10.1007/s00464-020-07471-1. Epub 2020 Feb 27.

  PMID: 32107632 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Esophageal Neoplasms; Stomach Neoplasms; Fistula; Anastomotic Leak

Interventions

Stents

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Carlos Noronha Ferreira, MD, MSc, PhD

  Serviço de Gastrenterologia e Hepatologia, Unidade Local de Saúde Santa Maria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)