Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

NCT02394327 | Completed

• 1 other identifier: AJIRB-MED-MDB-11-318
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%. Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route. Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.

Conditions

Cholecystitis, Acute; Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (1)

• Techncal success rate

  This outcome was defined as successful deep GB cannulation and placement of assigned drainage device by randomization, and determined by the operator based on the fluoroscoic images of the procedures.

  From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours

Secondary Outcomes (2)

• Clinical success rate

  From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours

• early adverse event

  From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks

Study Arms (2)

Endoscopic nasogallbladder drainage

ACTIVE COMPARATOR

If GB cannulation was achieved and the wire was coiled in the GB, 5 to 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB

Device: 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)

Endoscopic gallbladder stenting

ACTIVE COMPARATOR

If GB cannulation was achieved and the wire was coiled in the GB, 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB

Device: 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)

Interventions

7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) DEVICE

Endoscopic

Endoscopic nasogallbladder drainage

7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) DEVICE

Endoscopic gallbladder stenting

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria
• a high suspicion of CBD stone based on laboratory and imaging study
• informed consent given.

You may not qualify if:

• bilo-pancreatic malignancy or surgically altered enteric anatomy
• subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggido, 443-380, South Korea

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Gallstones

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Byung Moo Yoo, MD

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 20, 2015
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

KR (1)