RecruitingNot ApplicableNCT05702775

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

Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)

Sponsor

Fundacion Miguel Servet

Enrollment

100 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Cholecystitis, Acute

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.

Eligibility

Inclusion Criteria4

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

Exclusion Criteria11

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

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Interventions

PROCEDUREEndoscopic treatment group (EUS-GBD group

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.