Clinical trial NCT02394327: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis, Acute
Common Bile Duct Calculi
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Techncal success rate
timeFrame: From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours
Secondary outcomes:
measure: Clinical success rate
timeFrame: From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours
measure: early adverse event
timeFrame: From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
Study officials:
affiliation: Ajou University School of Medicine
name: Byung Moo Yoo, MD
role: STUDY_DIRECTOR
References: