Preoperative Biliary Drainage in Malignant Biliary Obstruction

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04847297

Acronym

PEAR

Enrollment

353

Registered

2021-04-19

Start date

2021-09-01

Completion date

2026-12-31

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer, biliary drainage, pancreato-duodenectomy

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.

Interventions

PROCEDUREPreoperative drainage and pancreatoduodenectomy

Preoperative biliary drainage before surgical removal of the tumor

PROCEDUREPancreatoduodenectomy

Pancreatic tumor resection without previous preoperative biliary drainage

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
rate of serious complications	120 days	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

Secondary

Measure	Time frame	Description
Length of hospitalization	120 days	Length of hospitalization after biliary drainage and surgery
Mortality	30 days	Rate of mortality among groups

Contacts

Primary ContactÁkos Szűcs

szucs.akos@gmail.com06305359443

Backup ContactPéter Hegyi

hegyi2009@gmail.com06703751031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026