NCT07606430Not yet recruiting
Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction
Multicenter Randomized Trial of a Short Modified 8-mm-diameter Fully Covered Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction. In patients who require biliary drainage before surgery, stent placement is commonly performed using endoscopic retrograde cholangiopancreatography (ERCP). However, the optimal stent type remains uncertain. Participants will be randomly assigned to receive either the modified FCSEMS or a plastic stent. The primary objective is to evaluate the rate of stent-related complications requiring reintervention before surgery. Secondary outcomes include stent patency, adverse events, and surgical outcomes. The results of this study are expected to help determine the most appropriate stent strategy for patients undergoing surgery for pancreatic cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 6 May 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Soonchunhyang University Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT07606430
What you commit to
- Study type: Interventional
- Planned participants: 116
- From 1 May 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior biliary stent placement for biliary obstruction
Other illness
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study outcomes
Other
- Presence of distant metastasis
- Requirement for duodenal stent placement due to gastric outlet obstruction
- Estimated life expectancy \< 3 months
- Inability to undergo ERCP
Who the study is looking for
- Age ≥ 18 years
- Patients with resectable, borderline resectable, or locally advanced pancreatic cancer with distal malignant biliary obstruction requiring endoscopic biliary drainage
- Biliary stricture located ≥ 2 cm below the hepatic hilum
- Serum bilirubin ≥ 3 mg/dL
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to provide written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.