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

NCT03358095 | Withdrawn

• 1 other identifier: Early surgery vs PBD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Biliary Stasis

Outcome Measures

Primary Outcomes (1)

• Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery

  120 days after surgery

Study Arms (2)

Early surgery

NO INTERVENTION

Patients in this group proceed to pancreatic resection within 2 week of recruitment.

Preoperative biliary drainage

ACTIVE COMPARATOR

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.

Device: Tannenbaum Fr 10 stent or WallFlex stent

Interventions

Tannenbaum Fr 10 stent or WallFlex stent DEVICE

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

Preoperative biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (2)

• van der Gaag NA, Kloek JJ, de Castro SM, Busch OR, van Gulik TM, Gouma DJ. Preoperative biliary drainage in patients with obstructive jaundice: history and current status. J Gastrointest Surg. 2009 Apr;13(4):814-20. doi: 10.1007/s11605-008-0618-4. Epub 2008 Aug 23.

  PMID: 18726134 BACKGROUND

• van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.

  PMID: 20071702 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholestasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Sini Vehviläinen, MD

  Helsinki University Central Hospital

  STUDY CHAIR

• Hanna Seppänen, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Arto Kokkola, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Marianne Udd, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Outi Lindström, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Johanna Louhimo, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: November 30, 2017
• Study Start: November 26, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)