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Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

NCT03729882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-07-28

No results posted yet for this study

Summary

to determine if primary prophylaxis with Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) in unresectable cancer patients with the orifice of the cystic duct (OCD) involvement is superior to conservative management (Non EUS-guided gallbladder drainage).

Conditions

  • Acute Cholecystitis

Interventions

PROCEDURE

EUS-guided gallbladder drainage

During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. A prophylaxis gallbladder drainage will be done using a 3.8 mm working-channel linear-array therapeutic echoendoscope (EG3870UTK;Pentax, Hamburg, Germany) attached to an ultrasound console (Avius Hitachi, Tokyo, Japan) within a transgastric and/or transduodenal approaches to the gallbladder puncture followed by placement of a lumen apposing stent (LAMS) (AXIOS; Xlumena Inc, CA, USA) with a 10 mm luminal diameter and a dumbbell-shaped flanges to bring together the 2 walls in apposition. These feature of the Axios decrease the risk for bile leak, stent migration, and stent occlusion.

PROCEDURE

Non EUS-guided gallbladder drainage

During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. If the patient had an acute cholecystitis will be sent to surgery and be considered as a Non EUS-guided gallbladder drainage

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda · Instituto Ecuatoriano de Enfermedades Digestivas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-12-27
Completion
2020-07-27

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729882 on ClinicalTrials.gov