Routine Nasobiliary Insertion During ERCP in High Risk Patients.
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 12, 2018
February 1, 2018
2.3 years
August 30, 2016
February 9, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
biliary injury
the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative
2 weeks
conversion to open
incidence of conversion to open
6 hours
Secondary Outcomes (3)
operative time
6 hours
hospital stay
one month
mortality
one month
Study Arms (2)
ERCP with nasobiliary catheter
EXPERIMENTALERCP only
ACTIVE COMPARATORInterventions
ERCP with NB catheter for introperative tans-nasobiliary cholangiography
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients\< 18 and \>80
- unfit for surgery
- didn't accept to share in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minya university hospital
Minya, 61511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 5, 2016
Study Start
April 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
February 12, 2018
Record last verified: 2018-02