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

NCT ID: NCT03358095

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-26
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early surgery

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Preoperative biliary drainage

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.

Group Type: ACTIVE_COMPARATOR

Tannenbaum Fr 10 stent or WallFlex stent

Intervention Type: DEVICE

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

Interventions

Tannenbaum Fr 10 stent or WallFlex stent

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Leena Kylanpaa

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sini Vehviläinen, MD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Hanna Seppänen, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Arto Kokkola, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Marianne Udd, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Outi Lindström, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Johanna Louhimo, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Locations

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 18726134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20071702 (View on PubMed)

Other Identifiers

Early surgery vs PBD

Identifier Type: -

Identifier Source: org_study_id