Routine Nasobiliary Insertion During ERCP in High Risk Patients.

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Gallstones Complicated by CBD Stones

Intervention / Treatment
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* Procedure: ERCP with NB
* Procedure: ERCP alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |