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

• ClinicalTrials.gov Identifier: NCT03358095
• Recruitment Status: Withdrawn
• First Posted: November 30, 2017
• Last Update Posted: May 20, 2021
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Leena Kylanpaa, Helsinki University Central Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer; Biliary Stasis	Device: Tannenbaum Fr 10 stent or WallFlex stent	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage? A Prospective Study
• Actual Study Start Date: November 26, 2017
• Estimated Primary Completion Date: December 31, 2025
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Early surgery; Patients in this group proceed to pancreatic resection within 2 week of recruitment.
Active Comparator: 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.	Device: Tannenbaum Fr 10 stent or WallFlex stent; A plastic or metallic endoprosthesis is placed to the biliary ducts.

Outcome Measures

Primary Outcome Measures :

1. Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery [ Time Frame: 120 days after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Finland

Helsinki University Hospital

Helsinki, Uusimaa, Finland, 00029

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

• Study Chair: 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

More Information

Publications:

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. Review.

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.

• Responsible Party: Leena Kylanpaa, Head of department, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT03358095
• Other Study ID Numbers: Early surgery vs PBD
• First Posted: November 30, 2017
• Last Update Posted: May 20, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Head and Neck Neoplasms; Cholestasis; Neoplasms by Site; Neoplasms; Digestive System Diseases; Bile Duct Diseases; Biliary Tract Diseases