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Not yet recruiting NCT04847297

Preoperative Biliary Drainage in Malignant Biliary Obstruction

— Observational Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative drainage and pancreatoduodenectomy, Pancreatoduodenectomy.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study

Overview

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.

Interventions

  • Procedure Preoperative drainage and pancreatoduodenectomy
    Preoperative biliary drainage before surgical removal of the tumor
  • Procedure Pancreatoduodenectomy
    Pancreatic tumor resection without previous preoperative biliary drainage

Primary outcome measures

  • rate of serious complications [Time frame: 120 days]
  • rate of serious complications [Time frame: 120 days]
Secondary outcome measures (3)
  • Length of hospitalization [Time frame: 120 days]
  • Mortality [Time frame: 30 days]
  • Mortality [Time frame: 120 days]

Eligibility criteria

Inclusion criteria

  • Patients ≥ 18 years
  • OJ of malignant origin (pancreatic head or periampullary tumor)
  • Total bilirubin level ≥ 40 μmol per liter
  • Signed written informed consent

Exclusion criteria

  • Proved metastasis
  • Irresectable tumor
  • Neo-adjuvant chemotherapy
  • Co-existing malignancy
  • Pregnancy
  • Patients not fit for resection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Abdeldayem 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
  • Assimakopoulos 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
  • Kuzu 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
  • Ito 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
  • Abraham 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
  • Kennedy 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
  • Minter 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. PMID 16153432
  • Sheen-Chen SM, Chau P, Harris HW. Obstructive jaundice alters Kupffer cell function independent of bacterial translocation. J Surg Res. 1998 Dec;80(2):205-9. doi: 10.1006/jsre.1998.5467. PMID 9878315

Identifiers

NCT: NCT04847297 · 40393-10/2020/EÜIG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗