Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

Not Applicable

Withdrawn

• Conditions: Biliary Stasis; Pancreatic Cancer
• Interventions: Device: Tannenbaum Fr 10 stent or WallFlex stent

• Registration Number: NCT03358095
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-26
• Study First Submitted: 2017-11-26
• Study First Submitted QC: 2017-11-26
• Study First Posted: 2017-11-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients in this study must have a resectable tumor of the head of the pancreas, and no evidence of distant metastasis or local vascular involvement. At the beginning of the study it's not necessary to have an accurate histologic diagnosis, the tumor might be malignant or benign. The patients also have jaundice with a total serum bilirubin level of 40-250µmol/l, and are fit enough to be considered for an early surgery.

Exclusion Criteria

• Patients with ongoing cholangitis, neoadjuvant treatments or previous biliary drainage with stenting by means of ERCP or PTC (Percutaneous Transhepatic Cholangiogram) are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative biliary drainage	Tannenbaum Fr 10 stent or WallFlex stent	Endoscopic retrograde cholangiopancreatography (ERCP) is used to place an endoprosthesis to the biliary ducts to drain biliary stasis, and the patients proceed to pancreatic resection within 6 weeks of recruitment.

Primary Outcome Measures

Name	Time	Method
Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery	120 days after surgery

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Uusimaa, Finland