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.
