Actively Recruiting

Phase Not Applicable
All Genders
NCT05702775

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

Led by Fundacion Miguel Servet · Updated on 2023-01-27

100

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient older than 18 years.
  • Definitive diagnosis of acute lithiasic cholecystitis according to GP Tokyo 2018 criteria.
  • Surgical decision of inoperable patient due to age �3e�3d 80 years, ASA III or more, Charlson Comorbidity Index > 5, Karnofsky < 50, or patient's choice not to have surgery.
  • Signed informed consent for study participation.
Not Eligible

You will not qualify if you...

  • Operable acute cholecystitis.
  • Patient refusal to participate in the study.
  • Altered gastrointestinal anatomy from previous hepatobiliary or upper GI surgery.
  • Presence of ascites.
  • Unable to tolerate sedation or with contraindications to endoscopy.
  • Decompensated cirrhosis, portal hypertension, or gastric varices.
  • Uncorrectable coagulopathy with INR > 1.5 or thrombocytopenia < 50,000/mm3.
  • Other diagnoses on admission such as choledocholithiasis, liver abscess, acute pancreatitis, or biliopancreatic tumors.
  • Hemodynamic instability.
  • Baseline ECOG performance status of 4 or higher.
  • Life expectancy less than 6 months.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitario de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

J

Jesús JU Urmán, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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