Clinical trial NCT03358095: Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?
Official title: Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage? A Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Cancer
Biliary Stasis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery
timeFrame: 120 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Sini Vehviläinen, MD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Hanna Seppänen, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Arto Kokkola, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Marianne Udd, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Outi Lindström, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Johanna Louhimo, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.