Cholangitis, Cholecystitis, Pancreatitis
Conditions
Brief summary
In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.
Detailed description
This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.). Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.
Interventions
DEVICETracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
Sponsors
Soon Chun Hyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance
Exclusion criteria
* refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success rate between DGT and TPS | up to 22months | from October 2010 to August 2012 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| median cannulation time between DGT and TPS | during precedure time | median time for precedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| pancreatitis rate between DGT and TPS | upto 1 week | We observation for the comlication upto 1 week after ERCP |
Countries
South Korea
Outcome results
None listed