Biliary Obstruction Due to Common Bile Duct Stone, Malignant Bile Duct Obstruction
Conditions
Keywords
jaundice, bile duct obstruction, abnormal liver enzymes
Brief summary
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
Interventions
PROCEDURENeedle Knife Fistulotomy
Biliary access using needle knife fistulotomy technique
PROCEDUREstandard biliary cannulation
standard biliary cannulation
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
older than 18 years of age -
Exclusion criteria
if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post ERCP pancreatitis | within 48 hours of the procedure | Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | within 48 hours | Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis |
| Perforation | within 48 hours | Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure. |
Countries
United States
Outcome results
None listed