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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03358095

Enrollment

Registered

2017-11-30

Start date

2017-11-26

Completion date

2025-12-31

Last updated

2021-05-20

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

Conditions

Biliary Stasis, Pancreatic Cancer

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.

Interventions

DEVICETannenbaum Fr 10 stent or WallFlex stent

A plastic or metallic endoprosthesis is placed to the biliary ducts.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery	120 days after surgery

Countries

Finland

Outcome results

None listed

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