Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis

NCT05702775 | Recruiting

• 1 other identifier: Jesús María Urmán Fernández
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs. The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC. Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.

Conditions

Cholecystitis, Acute

Keywords

Cholecystitis; Non-operable; Endoscopic

Outcome Measures

Primary Outcomes (1)

• Cumulative rate of biliopancreatic events development at one year of follow-up

  Biliopancreatic event (BPE): event related to biliary pathology such as acute cholecystitis, acute cholangitis, symptomatic choledocholithiasis, acute pancreatitis mild-moderate, severe acute pancreatitis, biliary colic (complicated or uncomplicated), liver abscess

  2 years

Secondary Outcomes (8)

• Proportion of technical success of EUS-GBD and the complications

  2 years

• Evaluate healing and time to healing of acute cholecystitis

  2 years

• Evaluate the duration of the index admission

  2 years

• Evaluate the duration of antibiotic treatment

  2 years

• Evaluate the need for percutaneous cholecystostomy

  2 years

Study Arms (2)

Non-endoscopic treatment group (Group NE)

NO INTERVENTION

Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018, CAL will be classified into three groups according to severity (I,II,III) and empirical antibiotic treatment will be started according to the recommendations of said guideline

Endoscopic treatment group (EUS-GBD Group)

EXPERIMENTAL

The procedure will be performed after at least 6 hours of fasting The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy.

Procedure: Endoscopic treatment group (EUS-GBD group

Interventions

Endoscopic treatment group (EUS-GBD group PROCEDURE

The placement of a endoscopic drain performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. Subsequently, the interior of the gallbladder will be irrigated with saline solution until the vesicular content comes out.

Endoscopic treatment group (EUS-GBD Group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years.
• Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.
• Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index \> 5 and/or Karnofsky \< 50 or decision of the patient not to have surgery.
• Signature of the informed consent of the study

You may not qualify if:

• Operable acute cholecystitis.
• Refusal of the patient to participate in the study.
• Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery.
• Ascites.
• Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy.
• Patients with decompensated cirrhosis, portal hypertension and/or gastric varices
• Coagulopathy with uncorrectable INR\>1.5 or thrombocytopenia \<50,000/mm3 uncorrectable.
• Other diagnoses on admission (choledocholithiasis, liver abscesses, acute pancreatitis or biliopancreatic neoplasia).
• Hemodynamic instability.
• Baseline ECOG \>=4
• Survival expectancy \< 6 months

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Jesús JU Urmán, PhD

CONTACT

+(34) 8484422222; jmurmanf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pancreas Unit

Model Details: Randomized, open-label, low-intervention, superiority clinical trial with parallel groups for the two treatment strategies.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: January 27, 2023
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)