Clinical trial · Observational
Preoperative Biliary Drainage in Malignant Biliary Obstruction
Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study
NCT04847297CI-TRIAL-00051328PEARnot yet recruitingClinicalTrials.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 first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.
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 |
|---|---|---|---|
| Pancreatoduodenectomy | Procedure | — | UNRESOLVED |
| Preoperative drainage and pancreatoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Preoperative biliary drainage and pancreatoduodenectomy
- description
- Patients receiving preoperative biliary drainage before the removal of the tumor.
- interventionNames
- Procedure: Preoperative drainage and pancreatoduodenectomy
- label
- Pancreatoduodenectomy only
- description
- Patients undergoing only surgical intervention, without preoperative drainage.
- interventionNames
- Procedure: Pancreatoduodenectomy
Primary outcomes (2)
- measure
- rate of serious complications
- timeFrame
- 120 days
- description
- rate of serious complications after preoperative biliary drainage and surgery 1. Pancreatitis 2. New onset of cholecystitis 3. Cholangitis 4. Perforation 5. Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP) 6. Related to stent 1. Occlusion 2. Need for exchange Related to surgery 7. Pancreas anastomosis leakage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥ 18 years 2. OJ of malignant origin (pancreatic head or periampullary tumor) 3. Total bilirubin level ≥ 40 μmol per liter 4. Signed written informed consent Exclusion Criteria: 1. Proved metastasis 2. Irresectable tumor 3. Neo-adjuvant chemotherapy 4. Co-existing malignancy 5. Pregnancy 6. Patients not fit for resection
References
Publications (34)
- BACKGROUNDAbdeldayem H, Ghoneim E, Refaei AA, Abou-Gabal A. Obstructive jaundice promotes intestinal-barrier dysfunction and bacterial translocation: experimental study. Hepatol Int. 2007 Dec;1(4):444-8. doi: 10.1007/s12072-007-9018-1. Epub 2007 Sep 20. PMID 19669340
- BACKGROUNDAssimakopoulos SF, Scopa CD, Vagianos CE. Pathophysiology of increased intestinal permeability in obstructive jaundice. World J Gastroenterol. 2007 Dec 28;13(48):6458-64. doi: 10.3748/wjg.v13.i48.6458. PMID 18161914
- BACKGROUNDKuzu MA, Kale IT, Col C, Tekeli A, Tanik A, Koksoy C. Obstructive jaundice promotes bacterial translocation in humans. Hepatogastroenterology. 1999 Jul-Aug;46(28):2159-64. PMID 10521960
- BACKGROUNDIto Y, Bethea NW, Baker GL, McCuskey MK, Urbaschek R, McCuskey RS. Hepatic microcirculatory dysfunction during cholestatic liver injury in rats. Microcirculation. 2003 Oct;10(5):421-32. doi: 10.1038/sj.mn.7800208. PMID 14557825
- BACKGROUNDAbraham S, Szabo A, Kaszaki J, Varga R, Eder K, Duda E, Lazar G, Tiszlavicz L, Boros M, Lazar G Jr. Kupffer cell blockade improves the endotoxin-induced microcirculatory inflammatory response in obstructive jaundice. Shock. 2008 Jul;30(1):69-74. doi: 10.1097/SHK.0b013e31815dceea. PMID 18562926
- BACKGROUNDKennedy JA, Clements WD, Kirk SJ, McCaigue MD, Campbell GR, Erwin PJ, Halliday MI, Rowlands BJ. Characterization of the Kupffer cell response to exogenous endotoxin in a rodent model of obstructive jaundice. Br J Surg. 1999 May;86(5):628-33. doi: 10.1046/j.1365-2168.1999.01114.x. PMID 10361183
- BACKGROUNDMinter RM, Fan MH, Sun J, Niederbichler A, Ipaktchi K, Arbabi S, Hemmila MR, Remick DG, Wang SC, Su GL. Altered Kupffer cell function in biliary obstruction. Surgery. 2005 Aug;138(2):236-45. doi: 10.1016/j.surg.2005.04.001.