Preoperative Biliary Drainage in Malignant Biliary Obstruction (PEAR)

University of Pecs

Status: Not yet enrolling

Conditions: Pancreatic Cancer

Treatments: Procedure: Pancreatoduodenectomy; Procedure: Preoperative drainage and pancreatoduodenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04847297

40393-10/2020/EÜIG

Details and patient eligibility

About

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.

Enrollment: 353 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

353 participants in 2 patient groups

Preoperative biliary drainage and pancreatoduodenectomy

Description:

Patients receiving preoperative biliary drainage before the removal of the tumor.

Treatment:

Procedure: Preoperative drainage and pancreatoduodenectomy

Pancreatoduodenectomy only

Description:

Patients undergoing only surgical intervention, without preoperative drainage.

Treatment:

Procedure: Pancreatoduodenectomy