Routine Nasobiliary Insertion During ERCP in High Risk Patients.

Not Applicable

Completed

• Conditions: Gallstones Complicated by CBD Stones
• Interventions: Procedure: ERCP with NB; Procedure: ERCP alone

• Registration Number: NCT02889471
• Lead Sponsor: Minia University

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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP with nasobiliary catheter	ERCP with NB	-
ERCP only	ERCP alone	-

Primary Outcome Measures

Name	Time	Method
conversion to open	6 hours	incidence of conversion to open
biliary injury	2 weeks	the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative

Secondary Outcome Measures

Name	Time	Method
mortality	one month	incidence of operative related mortality
operative time	6 hours	operative time from skin incision till closure
hospital stay	one month	time of hospital stay

Trial Locations

Locations (1)

Minya university hospital; 🇪🇬 Minya, Egypt