Clinical trial NCT04847297: Preoperative Biliary Drainage in Malignant Biliary Obstruction
Official title: Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
biliary drainage
pancreato-duodenectomy
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients diagnosed with malignant biliary obstruction who meet all the inclusion criteria but no exclusion criteria. All patients admitted with malignant biliary obstruction with- or without biliary intervention prior to the surgery in the participating hospitals will be assessed for eligibility

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: rate of serious complications
timeFrame: 120 days
measure: rate of serious complications
timeFrame: 120 days
Secondary outcomes:
measure: Length of hospitalization
timeFrame: 120 days
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 120 days
Other outcomes:
Locations:
Study officials:
affiliation: Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
name: Péter Hegyi
role: STUDY_CHAIR
affiliation: First Surgical Department of the University of Semmelweis
name: Ákos Szűcs
role: PRINCIPAL_INVESTIGATOR
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