Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)

NCT06967597 | Recruiting

• 1 other identifier: CEIm Ref: 2024/141 (2024-0434)
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with gallbladder inflammation (acute cholecystitis) who cannot undergo surgery due to their fragility and surgical risk require a gallbladder drainage. It has been confirmed in previous studies that the gallbladder drainage from the digestive tract is a better alternative, because it has fewer complications than external (percutaneous) gallbladder drainage. However, there are no known studies that demonstrate whether it is better to maintain this drainage indefinitely, or to carry out periodic revisions of the drainage to progressively remove the stones lodged in the gallbladder and remove the drainage once this has been achieved. In this study we aim to compare the clinical evolution of patients who undergo this gallbladder drainage, dividing them into two groups:

• One group of patients in whom we maintain a metallic prosthesis or stent, which communicates the gallbladder with the stomach, indefinitely in order to always guarantee a drainage of the bile towards the digestive tract, and thus avoid new episodes of cholecystitis.
• Another group of patients who, one month after having undergone drainage, undergo a new procedure to remove the gallbladder lithiasis, until it is empty and without inflammation and we can remove the metal stent, leaving only a very thin plastic catheter to maintain the fistula and thus the bile continues to flow into the digestive tract. More than one procedure may be required to completely clear the gallbladder. Knowledge of whether one strategy or the other presents fewer complications in the short, medium and long term is essential to be able to offer the best alternative to our patients. The aim of the study is to compare the clinical outcome of these patients who have a definitive drain inserted with those who undergo several procedures to clear the gallbladder until the drain is removed. The rate of complications, the need for re-interventions and hospital admissions, new episodes of acute cholecystitis, quality of life and mortality of both groups over a period of one year are compared.

Conditions

Acute Cholecystitis

Keywords

EUS-guided gallbladder drainage; acute cholecystitis; interventional endoscopic ultrasonography; lumen apposing metal stents; percutaneous cholecystostomy

Outcome Measures

Primary Outcomes (1)

• Biliopancreatic events (BPE)

  The primary aim is to assess the difference in terms of recurrence of the combined variable of biliopancreatic events (biliary colic, cholangitis, choledocholithiasis, acute cholecystitis or acute pancreatitis) between the active treatment group and the conservative treatment group during follow-up period.

  From enrollment until 12 months after

Secondary Outcomes (8)

• Recurrence of each of the variables that make up the combined variable BPE separately

  From enrollment until 12 months after

• Total complication rate

  From enrollment until 12 months after

• Unplanned reintervention rate

  From enrollment until 12 months after

• Biliary cause admission rate

  From enrollment until 12 months after

• Disease-Free survival

  From enrollment until 12 months after

Study Arms (2)

Cholecystoscopy, gallbladder cleaning and removal of lumen-apposing metal stent

ACTIVE COMPARATOR

Elective upper gastrointestinal endoscopy to perform cholecystoscopy, cleaning and removal of gallbladder (GB) stones and retrieval of the Lumen Apposing Metal Stent (LAMS) will be conducted 1 month after endoscopic ultrasound-guided GB drainage. For persistent GB stones, consecutive procedures will be performed weekly until complete cleaning and retrieval of the LAMS. A coaxial double pigtail plastic stent (7 or 10 Fr x 3 cm) will be placed indefinitely to maintain the fistula between the GB and the digestive tract.

Procedure: Cholecystoscopy and gallbladder cleaning

Conservative treatment: Indwelling stent

NO INTERVENTION

Patients in the conservative group will not be scheduled for endoscopic revision during the one-year follow-up. The LAMS will only be reviewed as part of routine practice for suspected LAMS related complications

Interventions

Cholecystoscopy and gallbladder cleaning PROCEDURE

Upper gastrointestinal endoscopy and cholecystoscopy are performed 4 weeks after GB drainage. A standard gastroscope is used to inspect the gallbladder cavity with retrieval or lithotripsy of residual stones until complete cleaning of the GB is achieved. Several procedures may be required to achieve complete stone clearance. Finally, the LAMS is retrieved and replaced with a double pigtail plastic stent.

Cholecystoscopy, gallbladder cleaning and removal of lumen-apposing metal stent

Eligibility Criteria

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

You may qualify if:

• Patient ≥ 18 years of age
• Confirmed acute cholecystitis diagnosed according to Tokyo 2018 criteria.
• Patient unfit for surgery: if meets one or more of the following criteria: age ≥ 80 years, American Society of Anesthesiology (ASA) ≥ III, Charlson Comorbidity Index \> 5 and/or Karnofsky \< 50, or patient unwilling to undergo surgery.
• Gallbladder drainage by LAMS stent.
• Informed Consent signed

You may not qualify if:

• Patient refusal to participate in the study
• Gastrointestinal surgically modified anatomy preventing endoscopic access to the gallbladder.
• Technical failure to perform endoscopic ultrasound guided-gallbladder drainage.
• Moderate or severe ascites.
• Severe coagulopathy International Normalized Ratio \>1.5 and/or fibrinogen \<120) or thrombocytopenia (platelets \<20,000).
• Patient unable to tolerate sedation or general anesthesia
• Haemodynamically unstable patient
• Life expectancy \<6 months
• Baseline ECOG ≥4
• Patient with ongoing malignancy
• Pregnancy
• Acute pancreatitis

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

Study Sites (2)

Hospital Universitario Dr Balmis Alicante

Alicante, Alicante, 03010, Spain

NOT YET RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, Alicante, 03015, Spain

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

José Ramón Aparicio Tormo, MD

CONTACT

(0034)965933468; japariciot@gmail.com

Pedro López-Muñoz, MD

CONTACT

(0034)965933468; pedro.lopez8928@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)