Routine Nasobiliary Insertion During ERCP in High Risk Patients.

Routine Nasobiliary Insertion During ERCP to Prevent, Diagnose and Treat of Biliary Injury in High Risk Patients.

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

Study Overview

• Status: Completed
• Conditions: Gallstones Complicated by CBD Stones
• Intervention / Treatment: Procedure: ERCP with NB; Procedure: ERCP alone

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61511
    • Minya university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERCP with nasobiliary catheter	Procedure: ERCP with NB; ERCP with NB catheter for introperative tans-nasobiliary cholangiography
Active Comparator: ERCP only	Procedure: ERCP alone; ERCP alone followed with standard laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	operative time from skin incision till closure	6 hours
hospital stay	time of hospital stay	one month
mortality	incidence of operative related mortality	one month

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Gallstones
• Other Study ID Numbers: fac.med.07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No