Stanford University
Subhas Banerjee
The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.
Biliary Disease
Pancreatic Disease
ChoppedOcholiasis
Biliary Obstruction
Biliary Tract Neoplasms
Pancreatic Neoplasms
Duodenoscope with single-use distal cover
Conventional duodenoscope
NA
The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 600 participants |
| Masking : | DOUBLE |
| Primary Purpose : | OTHER |
| Official Title : | Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial |
| Actual Study Start Date : | 2022-10-25 |
| Estimated Primary Completion Date : | 2024-12-31 |
| Estimated Study Completion Date : | 2024-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Stanford hospital
Palo Alto, California, United States, 943305