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

NCT ID: NCT07048977

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-10-28

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.

Detailed Description

Purpose of the Study

This research compares two different advanced techniques used during a special endoscopy procedure (called ERCP) when it is difficult to insert a tube into the bile duct. The goal is to see which method is more successful, takes less time, and causes fewer complications:

Needle-knife precut over a pancreatic stent, and

Transpancreatic sphincterotomy (cutting through the pancreatic opening).

Who Can Join the Study?

Patients may be invited to join this study if they:

Are at least 20 years old

Are receiving their first ERCP treatment

Agree to sign a consent form

Who Cannot Join the Study?

Patients cannot join if they:

Take blood thinners or have bleeding problems

Have tumors causing narrowing in the bile duct or nearby areas

Have certain types of growths near the bile duct opening

Have abnormal intestines from previous surgery

Are currently pregnant

Have active pancreatitis (inflammation of the pancreas)

Have serious infections with symptoms like low blood pressure or difficulty breathing

How the Study Works From November 2021 to October 2023, about 400 patients will be recruited at Kaohsiung Chang Gung Memorial Hospital. If the doctor cannot insert the tube into the bile duct after 5 minutes or if the guidewire enters the pancreatic duct 3 times without success, the patient will be considered to have "difficult cannulation."

Some patients will be placed into groups based on the shape of the bile duct area.

Others will be randomly assigned to one of two groups (like flipping a coin):

Needle-knife precut over a pancreatic stent

Transpancreatic sphincterotomy followed by pancreatic stent placement

Risks and Safety

These procedures are considered safe but can have side effects. Based on past studies:

Pancreatitis (inflammation of the pancreas) may occur in about 6-10% of cases

Bleeding or perforation (a small tear in the intestine) is rare, around 0-2%

Death is very rare, less than 0.5%

Using a pancreatic stent can lower the risk of pancreatitis by about half. However, in very rare cases, the stent might move and require another procedure to remove it.

After the procedure, the patient must not eat or drink until the next day. The medical team will watch for signs of complications such as belly pain, black stool, fever, or confusion. If any of these happen, the doctor will take immediate action. If the patient feels fine the next day, they can slowly begin to eat soft or liquid food.

Joining is Voluntary Participation in the study is completely voluntary. If the patient chooses not to join, it will not affect their regular medical care in any way.

Conditions

ERCP Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NKP-SIPS group

knife precut papillotomy following the pancreas stent placement

Group Type: EXPERIMENTAL

Needle-Knife Precut Papillotomy over Pancreatic Stent

Intervention Type: 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)

TPS group

Tranpancreatic sphincterotomy followed by the pancreas stent placement

Group Type: ACTIVE_COMPARATOR

Transpancreatic Sphincterotomy

Intervention Type: 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.

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)

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liang Chih-Ming

Deputy Director of Division of Hepato-Gastroenterology, Clinical Associate Professor.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Others, Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 28609791 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26990509 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IRB 202101221A3

Identifier Type: OTHER

Identifier Source: secondary_id

IRB 202101221A3

Identifier Type: -

Identifier Source: org_study_id