Routine Nasobiliary Insertion During ERCP in High Risk Patients.
Atslēgvārdi
Abstrakts
Apraksts
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
Datumi
Pēdējoreiz pārbaudīts: | 01/31/2018 |
Pirmais iesniegtais: | 08/29/2016 |
Paredzētā reģistrācija iesniegta: | 08/29/2016 |
Pirmais izlikts: | 09/04/2016 |
Pēdējais atjauninājums iesniegts: | 02/08/2018 |
Pēdējā atjaunināšana ievietota: | 02/11/2018 |
Faktiskais studiju sākuma datums: | 03/31/2015 |
Paredzamais primārās pabeigšanas datums: | 07/31/2017 |
Paredzamais pētījuma pabeigšanas datums: | 07/31/2017 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Procedure: ERCP with nasobiliary catheter
Procedure: ERCP only
Fāze
Roku grupas
Roka | Iejaukšanās / ārstēšana |
---|---|
Experimental: ERCP with nasobiliary catheter | Procedure: ERCP with nasobiliary catheter ERCP with NB catheter for introperative tans-nasobiliary cholangiography |
Active Comparator: ERCP only | Procedure: ERCP only ERCP alone followed with standard laparoscopic cholecystectomy |
Atbilstības kritēriji
Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
Dzimumi, kas ir piemēroti studijām | All |
Pieņem veselīgus brīvprātīgos | Jā |
Kritēriji | 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 |
Rezultāts
Primārie rezultāti
1. biliary injury [2 weeks]
2. conversion to open [6 hours]
Sekundārie iznākuma mērījumi
1. operative time [6 hours]
2. hospital stay [one month]
3. mortality [one month]