Preoperative Biliary Drainage in Malignant Biliary Obstruction

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Pancreatoduodenectomy; Procedure: Preoperative drainage and pancreatoduodenectomy

• Registration Number: NCT04847297
• Lead Sponsor: University of Pecs

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-20
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-19
• Last Update Posted: 2021-04-19
• Study Start: 2021-09-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 353

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatoduodenectomy only	Pancreatoduodenectomy	Patients undergoing only surgical intervention, without preoperative drainage.
Preoperative biliary drainage and pancreatoduodenectomy	Preoperative drainage and pancreatoduodenectomy	Patients receiving preoperative biliary drainage before the removal of the tumor.

Primary Outcome Measures

Name	Time	Method
rate of serious complications	120 days	rate of serious complications after preoperative biliary drainage and surgery defined as: 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 Outcome Measures

Name	Time	Method
Length of hospitalization	120 days	Length of hospitalization after biliary drainage and surgery
Mortality	120 days	Rate of mortality among the groups