Back to resultsRoutine Nasobiliary Insertion During ERCP in High Risk Patients.
Primary Purpose
Gallstones Complicated by CBD Stones
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ERCP with NB
ERCP alone
Sponsored by
About this trial
This is an interventional other trial for Gallstones Complicated by CBD Stones
Eligibility Criteria
Inclusion Criteria:
- patients with GB stone complicated with CBD stones
- accept to share in the study
- the presence of one or more preoperative predictors for high risk for difficult cholecystectomy
- patient fit for LC
Exclusion Criteria:
- patients< 18 and >80
- unfit for surgery
- didn't accept to share in the study
Sites / Locations
- Minya university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ERCP with nasobiliary catheter
ERCP only
Arm Description
Outcomes
Primary Outcome Measures
biliary injury
the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative
conversion to open
incidence of conversion to open
Secondary Outcome Measures
operative time
operative time from skin incision till closure
hospital stay
time of hospital stay
mortality
incidence of operative related mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02889471
Brief Title
Routine Nasobiliary Insertion During ERCP in High Risk Patients.
Official Title
Routine Nasobiliary Insertion During ERCP to Prevent, Diagnose and Treat of Biliary Injury in High Risk Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
5. Study Description
Brief Summary
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and methylene blue injected at the end of the procedure to detected any leak in NB group
Detailed Description
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy as , age > 65 , male sex, obesity, acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings i.e. distended gall bladder (GB), thickened GB wall, pericholecystic fluid collection and impacted stone etc. these patients admitted to department of surgery of Minia university hospital for ERCP followed with laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP to settle high up in the intrahepatic biliary tree after complete CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. sequential, multiple, step after step, tans-nasobiliary Intraoperative cholangiography was done during every step in cholecystectomy especially during dissection of calot's triangle and just before clipping of supposed cystic duct (CD) to make sure that the structure supposed to be CD was not the CBD. after the end of procedure methylene blue is injected from the the NB to detected any leak and if present
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones Complicated by CBD Stones
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERCP with nasobiliary catheter
Arm Type
Experimental
Arm Title
ERCP only
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ERCP with NB
Intervention Description
ERCP with NB catheter for introperative tans-nasobiliary cholangiography
Intervention Type
Procedure
Intervention Name(s)
ERCP alone
Intervention Description
ERCP alone followed with standard laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
biliary injury
Description
the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative
Time Frame
2 weeks
Title
conversion to open
Description
incidence of conversion to open
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
operative time
Description
operative time from skin incision till closure
Time Frame
6 hours
Title
hospital stay
Description
time of hospital stay
Time Frame
one month
Title
mortality
Description
incidence of operative related mortality
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with GB stone complicated with CBD stones
accept to share in the study
the presence of one or more preoperative predictors for high risk for difficult cholecystectomy
patient fit for LC
Exclusion Criteria:
patients< 18 and >80
unfit for surgery
didn't accept to share in the study
Facility Information:
Facility Name
Minya university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Routine Nasobiliary Insertion During ERCP in High Risk Patients.
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