Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

NCT ID: NCT02394327

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Endoscopic nasogallbladder drainage

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Endoscopic

Endoscopic gallbladder stenting

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Interventions

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

Endoscopic

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yoo Byung Moo

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byung Moo Yoo, MD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-MDB-11-318

Identifier Type: -

Identifier Source: org_study_id