Early NK Precut vs TPS in Difficult Cannulation: A RCT (ENKPT Trial)

Hello. This study is about a special kind of endoscopy called ERCP, which is used to treat bile duct infections, gallstones, and blockages that cause jaundice. Normally, doctors use a standard method to insert a tube into the bile duct during the procedure. However, even skilled doctors sometimes have trouble - in about 10% to 20% of patients, it's difficult to get the tube in. When this happens, doctors use advanced techniques called "precut" methods to help make the procedure successful. One of these is called "early needle-knife precut," which is done after trying for 5 minutes without success. Studies have shown this method can reduce the chance of getting pancreatitis (inflammation of the pancreas) afterward. There are two common types of these advanced techniques: Needle-knife precut over a pancreatic stent, which gently opens the area using a small cut over a temporary plastic tube. Transpancreatic sphincterotomy, which also helps open the duct through a different approach. Both methods can help the procedure succeed and have similar safety results. However, not many studies have compared these two methods early on in the procedure when a pancreatic stent is used. This study wants to compare them in a safe and scientific way. If you or your family member agrees to join, the doctor will explain everything clearly. Joining is completely voluntary, and saying "no" will not affect the medical care you receive.

NCT Number	NCT07048977
Lead Sponsor	Chang Gung Memorial Hospital
Conditions	ERCP Surgery
Enrollment	300 participants
Start Date	2021-12-01
Primary Completion	2025-09-28 (estimated)
Study Completion	2025-10-28 (estimated)
Updated on ClinicalTrials.gov	2025-07-03