Routine Nasobiliary Insertion During ERCP in High Risk Patients.

Gallstones Complicated by CBD Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889471
• Other study ID #: fac.med.07
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: February 9, 2018
• Start date: April 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gallstones
• Gallstones Complicated by CBD Stones

Intervention

Procedure:
• ERCP with NB
ERCP with NB catheter for introperative tans-nasobiliary cholangiography
• ERCP alone
ERCP alone followed with standard laparoscopic cholecystectomy

Locations

Country	Name	City	State
Egypt	Minya university hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biliary injury	the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative	2 weeks
Primary	conversion to open	incidence of conversion to open	6 hours
Secondary	operative time	operative time from skin incision till closure	6 hours
Secondary	hospital stay	time of hospital stay	one month
Secondary	mortality	incidence of operative related mortality	one month