Skip to main content
OpenTrials
Completed

NCT Number: NCT03729882

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Cholecystitis Adenocarcinoma Biliary Tract Diseases Carcinoma Cholangiocarcinoma Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, 090505, Ecuador

About this study

Endoscopic biliary drainage with a self-expandable metal stent (SEMS) is an accepted form of palliative therapy for distal malignant biliary obstruction (MBO); it is a low invasive procedure with a long-term patency.

Covered SEMSs have a longer patency than uncovered SEMSs in patients with MBO, because covered SEMSs can prevent tumor ingrowth. However, complications of covered SEMSs include stent occlusion, migration, kinking, non-occlusion cholangitis, liver abscess, pancreatitis and cholecystitis.

Nonsurgical decompression of the gallbladder is urgently needs to prevent sepsis, perforation and death in patients with acute cholecystitis. Several risk factors of cholecystitis after SEMS placement for distal MBO have been reported: however, tumor involvement to the orifice of the cystic duct (OCD) is the major predictive factor for cholecystitis after endoscopic SEMSs placement for distal MBO palliative treatment .

Acute cholecystitis related to SEMSs deployment was evaluated in 2009, by using endoscopic trans-papillary gallbladder drainage (TPGBD) in 11 individuals in whom SEMSs covered the OCD. None episode of cholecystitis was reported, however TPGBD is a difficult technique with a high rate of stent dislodgement and reintervention needed.

EUS-GBD by using a lumen apposing metal stent have been proposed, but only for acute cholecystitis treatment or symptomatic gallbladder hydrops, never as a prophylactic technique.

The aim of this study if to determine if primary prophylaxis EUS-GBD in patients with distal malignant biliary obstruction and the OCD involvement is superior than conservative management. Also, a cost-effectiveness analysis will be done in both arm groups.

This would be the first trial to study the effect of prophylactic EUS-GBD prior SEMSs deployment in patients with distal malignant biliary obstruction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 18 years old.
  • Obtained written consent for procedures
  • Unresectable malignant biliary obstruction diagnosed by Endoscopic Ultrasound and confirmed by confocal laser endomicroscopy (CLE) during cholangioscopy and histopathology.
  • Tumor involvement to the orifice of the cystic duct.
  • Self-expandable metallic plastic stent deployment as palliative therapy for distal biliary obstruction.

Exclusion criteria

  • Under 18 years old.
  • Refuse to sign written informed consent.
  • Pregnancy
  • Previous cholecystectomy
  • Acute cholecystitis prior enrollment
  • Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
  • Large vessel between the gallbladder and gastric-duodenal wall.
  • Coagulopathy
  • Intrahepatic cholangiocarcinoma
  • Previous gallbladder drainage by percutaneous or endoscopic techniques.

Treatment and study plan

EUS-guided gallbladder drainage

Procedure

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.

Non EUS-guided gallbladder drainage

Procedure

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

Primary outcomes

  1. Ocurrence of acute cholecystitis

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

    • Occurrence of acute cholecystitis according to Tokyo guidelines 2013: Clinical symptoms showing right upper or epigastric pain or tenderness, signs of systematic inflammation (fever, elevated white blood cell count, and C-reactive protein), or positive findings on abdominal ultrasonography (US) or computed tomography (CT).

Secondary outcomes

  1. Technical success rate: EUS-GBD

    Time frame: from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.

    as the ability of access and drain the gallbladder by placement of a drainage stent: lumen apposing metal stent ( Hot AXIOS™ Stent and Electrocautery Enhanced Delivered System; Boston Scientific Corporation, Natick, MA, USA).

  2. Clinical success rate:

    Time frame: since enrollment until 30-days follow up.

    non-occurrence of acute cholecystitis during follow up OR successful SEMS placement with biliary decompression and relief of jaundice pruritus.

  3. adverse events

    Time frame: from the beginning of the procedure until 30 days.

    any procedure-related adverse event (anesthesia, EUS-GBD, ERCP).

  4. presence of pus during EUS-GBD

    Time frame: immediate after EUS-GBD.

    endoscopic visualization of pus after EUS-GBD. Yes or no.

  5. Duration of the lumen apposing stent patency in the EUS-GBD arm study

    Time frame: the interval (days) between the time of stent placement and that of stent malfunction or patient death, whichever came first, assessed up to 12 months.

    Duration of the lumen apposing stent patency in the EUS-GBD arm study

  6. Need for gallbladder re-intervention.

    Time frame: from the end of the procedure until the date of first documented episode of acute cholecystitis through 12 months follow-up

    on EUS-GBD patients arm, need for a new gallbladder drainage (surgical or percutaneous) due to the occurrence of acute cholecystitis.

  7. Total length of hospital stay

    Time frame: from the beginning of hospitalization until discharge date or death since enrollment through 12 months follow-up

    it will be measured on both arms study when patients require hospitalization due to any procedure adverse event, cholecystitis and related procedures (cholecystectomy, percutaneous drainage)

  8. Total health-care related cost of both arm participants.

    Time frame: from the end of conventional biliary drainage until the date of 12 months follow-up.

    total health-are related cost in all participants from each arm.

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Registry information

Official study title

Prophylactic Endoscopic Ultrasound Gallbladder Drainage (EUS-GBD) in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 5, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.