ERCP Surgery
Conditions
Keywords
Early Needle-knife Precut Papillotomy, Transpancreatic Sphincterotomy, Difficult Cannulation
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.
Interventions
PROCEDURENeedle-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)
PROCEDURETranspancreatic 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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 ).
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of common bile duct (CBD) cannulation | During the ERCP procedure (up to 60 minutes) | Successful selective biliary cannulation using the assigned intervention during the index ERCP session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-ERCP pancreatitis (PEP) | Within 24 hours after ERCP | Defined as new or worsened abdominal pain with serum amylase \>3 times the upper limit of normal, requiring hospitalization or prolongation of hospital stay. |
| Incidence of perforation | Within 72 hours after ERCP | Bleeding categorized as mild (no transfusion), moderate (≤4 units transfused), or severe (≥5 units, angiography, or surgery), with a ≥2 g/dL hemoglobin drop or evidence of melena/hematemesis. |
Countries
Taiwan
Outcome results
None listed