Clinical trial · Interventional
Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors
"Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"
- 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 impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Obstruction | — | UNRESOLVED | — |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
| Preoperative Biliary Drainage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative Biliary Drainage (PBD) | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Direct Surgery (DS) group
- description
- patients subjected to direct surgery (DS) within 1 week after randomization
- interventionNames
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Preoperative Biliary Drainage (PBD) group
- description
- patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.
- interventionNames
- Procedure: Preoperative Biliary Drainage (PBD)
- Procedure: Surgery
Primary outcomes (2)
- measure
- Early postoperative mortality (within 3 months)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Serum bilirubin level above 4 mg/dl * suspected peri-ampullary tumor at computed tomography (CT) * No evidence of distant metastasis or locally advanced tumor Exclusion Criteria: * Patients with evidence of distant metastasis or locally advanced tumor * Prior neoadjuvant chemotherapy or Radiotherapy * Prior biliary surgery * Patients with contraindication for major surgery
References
Publications (4)
- BACKGROUNDWang C, Xu Y, Lu X. Should preoperative biliary drainage be routinely performed for obstructive jaundice with resectable tumor? Hepatobiliary Surg Nutr. 2013 Oct;2(5):266-71. doi: 10.3978/j.issn.2304-3881.2013.09.01. PMID 24570957
- BACKGROUNDMezhir JJ, Brennan MF, Baser RE, D'Angelica MI, Fong Y, DeMatteo RP, Jarnagin WR, Allen PJ. A matched case-control study of preoperative biliary drainage in patients with pancreatic adenocarcinoma: routine drainage is not justified. J Gastrointest Surg. 2009 Dec;13(12):2163-9. doi: 10.1007/s11605-009-1046-9. Epub 2009 Sep 23. PMID 19774424
- BACKGROUNDSmith RA, Dajani K, Dodd S, Whelan P, Raraty M, Sutton R, Campbell F, Neoptolemos JP, Ghaneh P. Preoperative resolution of jaundice following biliary stenting predicts more favourable early survival in resected pancreatic ductal adenocarcinoma. Ann Surg Oncol. 2008 Nov;15(11):3138-46. doi: 10.1245/s10434-008-0148-z. Epub 2008 Sep 12. PMID 18787902
- BACKGROUNDAbdullah SA, Gupta T, Jaafar KA, Chung YF, Ooi LL, Mesenas SJ. Ampullary carcinoma: effect of preoperative biliary drainage on surgical outcome. World J Gastroenterol. 2009 Jun 21;15(23):2908-12. doi: 10.3748/wjg.15.2908. PMID 19533815