Clinical trial · Interventional
SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice
Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interest in this study changed and it was decided to end enrollment early
Summary
Brief summary (as posted)
This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography | Procedure | — | UNRESOLVED |
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SEMS
- description
- Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
- interventionNames
- Procedure: Endoscopic Retrograde Cholangiopancreatography
- type
- ACTIVE_COMPARATOR
- label
- Standard of care surgical resection
- description
- Patients undergo standard of care surgical resection.
- interventionNames
- Other: Standard of care
Primary outcomes (2)
- measure
- Complication Rates of Grade III or Higher
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care * Serum bilirubin \> 10 mg/dl * Adequate birth control Exclusion Criteria: * Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) * Patients anticipated to require vascular reconstruction * Patients with cholangitis * Patients for whom surgery is deemed inappropriate by surgeon * Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL * Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC) * Patients with low performance score (Karnofsky performance status scale \< 50) * Patients with known preexisting liver disease with associated elevated bilirubin * Patients who are pregnant or actively breast feeding
References
Publications (0)
Data not yet available