Early NK Precut vs TPS in Difficult Cannulation: A RCT (ENKPT Trial)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal