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New treatment option for Chronic Pancreatitis
Official title Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
ClinicalTrials.gov ID: NCT06655051
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is: Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？ Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 or older;
- Patients diagnosed with CP;
- Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that...
- Confirmation of bile duct stricture by imaging assessment.
You likely can't join if
- Prior plastic stenting exceeding six months or any metal stenting;
- Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
- Biliary stricture of benign etiology other than chronic pancreatitis;
- Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
- Stricture within 2 cm of common bile duct bifurcation;
- Biliary stricture of malignant etiology;
See the full eligibility criteria
- Age 18 or older;
- Patients diagnosed with CP;
- Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted: cholangitis, and/or an increase...
- Confirmation of bile duct stricture by imaging assessment.
- Prior plastic stenting exceeding six months or any metal stenting;
- Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
- Biliary stricture of benign etiology other than chronic pancreatitis;
- Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
- Stricture within 2 cm of common bile duct bifurcation;
- Biliary stricture of malignant etiology;
- Patients with acute or chronic hepatitis, cirrhosis, primary sclerosing cholangitis, congenital biliary malformations or biliary fistula;
- Symptomatic duodenal stenosis (with gastric stasis);
- people for whom endoscopic techniques are contraindicated;
- Pregnancy, incarceration;
- Life expectancy \< 1 year;
- Other conditions that inappropriate to participant in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.