Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?
Key facts
- Who runs it
- Helsinki University Central Hospital
- Where
- Finland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 26 Nov 2017
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Tannenbaum Fr 10 stent or WallFlex stent
- Record updated
- 20 May 2021
- Why it stopped
- Investigators busy with other projects at the moment.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with ongoing cholangitis, neoadjuvant treatments or previous biliary drainage with stenting by means of ERCP or PTC (Percutaneous Transhepatic Cholangiogram) are excluded
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Early surgeryNo study treatment, for comparison
Patients in this group proceed to pancreatic resection within 2 week of recruitment.
- Preoperative biliary drainageExisting treatment, for comparison
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.
Treatment: Tannenbaum Fr 10 stent or WallFlex stent
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage? A Prospective Study
- Record updated
- 20 May 2021