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OpenTrials
Completed

NCT Number: NCT02889471

Routine Nasobiliary Insertion During ERCP 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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minya university hospital

Minya, 61511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP with NB

Procedure

ERCP with NB catheter for introperative tans-nasobiliary cholangiography

ERCP alone

Procedure

ERCP alone followed with standard laparoscopic cholecystectomy

Primary outcomes

  1. biliary injury

    Time frame: 2 weeks

    the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative

  2. conversion to open

    Time frame: 6 hours

    incidence of conversion to open

Secondary outcomes

  1. operative time

    Time frame: 6 hours

    operative time from skin incision till closure

  2. hospital stay

    Time frame: one month

    time of hospital stay

  3. mortality

    Time frame: one month

    incidence of operative related mortality

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2016
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.