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Routine Nasobiliary Insertion During ERCP in High Risk Patients.

M

Minia University

Status

Completed

Conditions

Gallstones Complicated by CBD Stones

Treatments

Procedure: ERCP alone
Procedure: ERCP with NB

Study type

Interventional

Funder types

Other

Identifiers

NCT02889471
fac.med.07

Details and patient eligibility

About

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

Full 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

Enrollment

80 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

ERCP with nasobiliary catheter
Experimental group
Treatment:
Procedure: ERCP with NB
ERCP only
Active Comparator group
Treatment:
Procedure: ERCP alone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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