Clinical Research Directory
Browse clinical research sites, groups, and studies.
Early NK Precut vs TPS in Difficult Cannulation: A RCT (ENKPT Trial)
Sponsor: Chang Gung Memorial Hospital
Summary
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.
Official title: Comparison of Early Needle-knife Precut Papillotomy Over a Pancreatic Stent and Transpancreatic Sphincterotomy in Difficult Cannulation: A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
20 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2021-12-01
Completion Date
2025-10-28
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
Needle-Knife Precut Papillotomy over Pancreatic Stent
If the papilla was treated with three unintended MPD cannulations, a needle-knife precut papillotomy with a small incision over a pancreatic stent (NKP-SIPS)
Transpancreatic Sphincterotomy
TPS was performed as Goff reported; in short, after cannulation of the pancreatic duct was achieved, a pull-sphincterotome on a guidewire was used to cut the septum between the bile and pancreatic ducts along the direction from 11 o'clock to 12 o'clock. After that, the pancreatic stent is placed first, and the sphincterotomy is extended to expose the biliary lumen, and the biliary duct can be cannulated.
Locations (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Others, Taiwan