Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

Cholecystitis, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394327
• Other study ID #: AJIRB-MED-MDB-11-318
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: January 4, 2016
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Common Bile Duct Calculi

Intervention

Device:
• 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)
Endoscopic
• 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical success rate	This outcome was defined as improvement of three clinical parameters of acute cholecystitis (fever, abdominal pain, leukocytosis) within 72 hours following either type of ETGD procedure, and assessed by the review of patient's mediacal records.	From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours	No
Secondary	early adverse event	This outcome was defined as any procedure related event occurring between the endoscopic procedure and elective cholecystectomy, and assessed by the patient's medical records.	From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks	Yes