NCT04847297Not yet recruiting
Preoperative Biliary Drainage in Malignant Biliary Obstruction
Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 19 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 353 (estimated)
- First submitted
- 20 Dec 2020
- Start date
- 1 Sept 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Pecs
- Diseases
- Pancreatic cancer
- NCT number
- NCT04847297
What you commit to
- Study type: Observational
- Planned participants: 353
- From 1 Sept 2021 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neo-adjuvant chemotherapy
- Patients not fit for resection
Other illness
- Co-existing malignancy
Other
- Proved metastasis
- Irresectable tumor
- Pregnancy
Who the study is looking for
- Patients ≥ 18 years
- OJ of malignant origin (pancreatic head or periampullary tumor)
- Total bilirubin level ≥ 40 μmol per liter
- Signed written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.