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

NCT06862479 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

PROCEDURE

Endoscopic management of fistulas with stents or vacum therapy

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.

Sponsors & Collaborators

  • Unidade Local de Saúde Santa Maria

    lead OTHER_GOV

Principal Investigators

  • Carlos Noronha Ferreira, MD, MSc, PhD · Serviço de Gastrenterologia e Hepatologia, Unidade Local de Saúde Santa Maria

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-01-01
Completion
2030-01-01

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862479 on ClinicalTrials.gov