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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cholecystoscopy and gallbladder cleaning: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Biliopancreatic events (BPE) — From enrollment until 12 months after
  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.

Trial sites (2)

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