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Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

Primary Purpose

Cholecystitis, Acute, Common Bile Duct Calculi

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)
7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis, Acute

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endoscopic nasogallbladder drainage

Endoscopic gallbladder stenting

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 18, 2015
Last Updated
January 4, 2016
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02394327
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute, Common Bile Duct Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic nasogallbladder drainage
Arm Type
Active Comparator
Arm 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
Arm Title
Endoscopic gallbladder stenting
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)
Intervention Description
Endoscopic
Intervention Type
Device
Intervention Name(s)
7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)
Primary Outcome Measure Information:
Title
Techncal success rate
Description
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.
Time Frame
From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours
Secondary Outcome Measure Information:
Title
Clinical success rate
Description
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.
Time Frame
From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours
Title
early adverse event
Description
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.
Time Frame
From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung Moo Yoo, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
443-380
Country
Korea, Republic of

12. IPD Sharing Statement

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Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

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