Brief Title
Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy
Official Title
Endoscopic Naso-gallbladder Drainage Versus Gallbladder Stenting Before Elective Cholecystectomy in Patients With Acute Cholecystitis and a High Suspicion of Common Bile Duct Stone; A Prospective Randomized Preliminary Study
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.
Study Type
Interventional
Primary Outcome
Techncal success rate
Secondary Outcome
Clinical success rate
Condition
Cholecystitis, Acute
Intervention
7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)
Study Arms / Comparison Groups
Endoscopic nasogallbladder drainage
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
35
Start Date
July 2011
Completion Date
December 2014
Primary Completion Date
December 2014
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
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Byung Moo Yoo, MD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02394327
Organization ID
AJIRB-MED-MDB-11-318
Responsible Party
Principal Investigator
Study Sponsor
Ajou University School of Medicine
Study Sponsor
Byung Moo Yoo, MD, Study Director, Ajou University School of Medicine
Verification Date
January 2016