Clinical trial · Interventional
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
NCT01774019CI-TRIAL-00065461completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.
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 Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- description
- Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)
- interventionNames
- Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- type
- NO_INTERVENTION
- label
- None (No Pre-Operative Biliary Drainage)
- description
- Patients in this group will not receive pre-operative biliary drainage with a study SEMS
Primary outcomes (1)
- measure
- Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last
- timeFrame
- 120 to 150 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Willing and able to comply with the study procedures and provide written informed consent to participate in the study * Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required) * Biliary obstructive symptoms or signs * Bilirubin level at/above 100 umol per liter (5.8 mg/dL) * Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy * Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum * Patients deemed as resectable by pancreatic protocol CT or MRI * Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion * Surgery intent within 4 weeks * Endoscopic and surgical treatment to be provided by same team Exclusion Criteria: * Biliary strictures caused by confirmed benign tumors * Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers * Surgically altered biliary tract anatomy, not including prior cholecystectomy * Neoadjuvant chemotherapy for current malignancy * Palliative indication due to reasons other than surgical candidate status * Previous biliary drainage by ERCP/PTC * Patients for whom endoscopic techniques are contraindicated * Participation in another investigational trial within 90 days * Pregnancy
References
Publications (1)
- DERIVEDCostamagna G, Reddy DN, Chia NH, Itoi T, Deviere J, Lee KF, Rao GV, Alfieri S, Lo I, Kasuya K, Closset J, Carr-Locke DL, Chandwani R, Peetermans J, Rousseau M, Lau J. Preoperative Biliary Drainage with Metal Stent Versus Early Surgery in Patients with Pancreatic Cancer: A Randomized Clinical Trial. Ann Surg Oncol. 2026 Jul;33(7):6801-6811. doi: 10.1245/s10434-026-19546-9. Epub 2026 Apr 8. PMID 41951900