Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Cannulation | Active Comparator | Standard Biliary Cannulation |
|
| NKF Cannulation | Experimental | Biliary Cannulation using NKF technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle Knife Fistulotomy | Procedure | Biliary access using needle knife fistulotomy technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| post ERCP pancreatitis | 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 | within 48 hours of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis | within 48 hours |
| Perforation | Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure. |
Not provided
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
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospial | Philadelphia | Pennsylvania | 19107 | United States |
Patients were not asked to consent for the data to be shared with other institutions
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007565 | Jaundice |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard biliary cannulation | Procedure | standard biliary cannulation |
|
| within 48 hours |
| D012816 | Signs and Symptoms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |