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

NCT07048977 | Active Not Recruiting DMC

• 1 other identifier: IRB 202101221A3
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ERCP Surgery

Keywords

Early Needle-knife Precut Papillotomy; Transpancreatic Sphincterotomy; Difficult Cannulation

Outcome Measures

Primary Outcomes (1)

• Success rate of common bile duct (CBD) cannulation

  Successful selective biliary cannulation using the assigned intervention during the index ERCP session.

  During the ERCP procedure (up to 60 minutes)

Secondary Outcomes (2)

• Incidence of post-ERCP pancreatitis (PEP)

  Within 24 hours after ERCP

• Incidence of perforation

  Within 72 hours after ERCP

Study Arms (2)

NKP-SIPS group

EXPERIMENTAL

knife precut papillotomy following the pancreas stent placement

Procedure: Needle-Knife Precut Papillotomy over Pancreatic Stent

TPS group

ACTIVE COMPARATOR

Tranpancreatic sphincterotomy followed by the pancreas stent placement

Procedure: Transpancreatic Sphincterotomy

Interventions

Needle-Knife Precut Papillotomy over Pancreatic Stent PROCEDURE

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)

NKP-SIPS group

Transpancreatic Sphincterotomy PROCEDURE

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.

TPS group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 20 years old and needed ERCP intervention for obstructive jaundice. They presented the "difficult CBD cannulation".

You may not qualify if:

• Patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD)
• Previous sphincterotomy,
• Peripapillary diverticula,
• Active pancreatitis,
• Prior gastric surgery,
• Current use of antiplatelet agents,
• Coagulopathy,
• Peri-ampullary tumor-related obstruction,
• Pregnancy,
• Refused or were unable to give informed consent

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Others, 833, Taiwan

Location

Related Publications (2)

• Pecsi D, Farkas N, Hegyi P, Balasko M, Czimmer J, Garami A, Illes A, Mosztbacher D, Par G, Parniczky A, Sarlos P, Szabo I, Szemes K, Szucs A, Vincze A. Transpancreatic sphincterotomy has a higher cannulation success rate than needle-knife precut papillotomy - a meta-analysis. Endoscopy. 2017 Sep;49(9):874-887. doi: 10.1055/s-0043-111717. Epub 2017 Jun 13.

  PMID: 28609791 RESULT

• Mariani A, Di Leo M, Giardullo N, Giussani A, Marini M, Buffoli F, Cipolletta L, Radaelli F, Ravelli P, Lombardi G, D'Onofrio V, Macchiarelli R, Iiritano E, Le Grazie M, Pantaleo G, Testoni PA. Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial. Endoscopy. 2016 Jun;48(6):530-5. doi: 10.1055/s-0042-102250. Epub 2016 Mar 18.

  PMID: 26990509 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are randomized into two groups at the time of providing informed consent by a 1:1 ratio, by opening a sealed envelope containing a noted marked with both groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Division of Hepato-Gastroenterology, Clinical Associate Professor.

Model Details: The "difficult CBD cannulation" was defined as unsuccessful CBD cannulation after 5 minutes (stopwatch count) or three passes of the guidewire into the MPD. If the patients with three passes of the guidewire into the MPD were randomly assigned, in a 1:1 ratio, to needle knife precut papillotomy following the pancreas stent placement (NKP-SIPS group) or tranpancreatic sphincterotomy followed by the pancreas stent placement (TPS group ).

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 3, 2025
• Study Start: December 1, 2021
• Primary Completion: September 28, 2025
• Study Completion: October 28, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)