Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01712971
First received: October 18, 2012
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Therefore, any significant reduction of intra-operative blood loss will benefit the peri-operative course.


Condition
Surgery
Pancreatic Tumour
Peri-ampullary Tumour
Blood Loss

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Randomized Trial on Standard Open Versus Minimally Invasive Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • intra-operative blood loss [ Time Frame: day 0 (at the end of surgery) ] [ Designated as safety issue: No ]
    the amount of intra-operative blood loss (ml) at the end of surgery (d0)


Secondary Outcome Measures:
  • Surgical resection margin [ Time Frame: day 30 ] [ Designated as safety issue: No ]
    Histopathological examination of surgical resection margins of the resection specimen; done within 30 days after surgery pR0: tumour-free resection margins pR1: tumour involvement of surgical resection margins

  • length of hospital stay after surgery [ Time Frame: day 30; 60; 90; 180 ] [ Designated as safety issue: No ]
    discharge from hospital after surgery

  • hospital costs [ Time Frame: year 1 & 2 ] [ Designated as safety issue: No ]
    final cost analysis


Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
OPD
standard open pancreaticoduodenectomy
LPD
laparoscopic pancreaticoduodenectomy

Detailed Description:

Pancreaticoduodenectomy (PD) is the only therapeutic option to cure patients suffering from pancreatic head or peri-ampullary tumors. The standard approach in PD is open surgery (OPD). With advancing technology, data from expert centers suggest minimally invasive or laparoscopic PD (LPD) to be safe and feasible, though randomized studies are lacking to show the clinical benefits of LPD vs. OPD.

Advantages of minimally invasive surgery over open surgery are reduced tissue damage, surgical trauma and immunosuppression.

The general objective of this study is to compare the intra-operative efficacy of LPD vs. OPD, and in particular the amount of intra-operative blood loss.

Study design Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.

Two experienced surgeons will perform all procedures; RA will perform the open and BT the laparoscopic procedures. A pylorus-resecting PD will be followed by a trans-mesocolic end-to-side hepatico-jejunostomy (HJS), a pancreatico-gastrostomy (PGS), and an ante-colic gastro-enterostomy (GES). Da Vinci robotic assistance of the reconstruction in LPD is allowed for the HJS and the PGS, while the GES will be done with endo-staplers.

Statistical considerations Randomization will take place pre-operatively after informed consent has been obtained. Patients will be randomized into two groups (OPD vs. LPD) using permuted blocks of size 6. This implies that of each series of 6 consecutive patients, three patients will be randomized in each group. There are no stratification variables.

Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.

Reference intra-operative blood loss levels are available from 138 patients (June 2009 - June 2012), without portal vein resection and without additional surgery. Analysis of these data reveals that these values follow a lognormal distribution; the log-transformed blood loss has a normal distribution with mean and standard deviation equal to 6.06 and 0.83, respectively. The corresponding geometric mean equals 427ml. Based on this distribution, 42.4%, 24.7% and 15.1% of the subjects are expected to have blood loss higher than 500, 750 and 1000 ml, respectively. It is assumed that the treatment (LPD) will lead to a 50% reduction of the (geometric) mean. The impact of this assumption on the distribution of the blood loss levels implies that 15.1%, 6.4% and 3.1% of the subjects in the LPD-group are expected to have a blood loss level higher than 500, 750 and 1000 ml, respectively.

Based on a two-sided two-sample pooled t-test of a mean ratio with lognormal data, a total of 50 subjects is needed to detect a two-fold reduction in blood loss (with alpha set at 5%) with 90% power.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suffering from pancreatic or peri-ampullary tumour

Criteria

Inclusion Criteria:

  • Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor
  • Age between 18 to 80 years
  • Patients with and without pre-operative biliary drainage (for obstructive jaundice)
  • Pre-operative radiotherapy, chemotherapy, or biological is allowed
  • PD for IPMN is allowed

Exclusion Criteria:

  • Planned concomitant surgical procedures such as simultaneous colonic resection etc.
  • Expected/planned reconstruction of the portal vein or superior mesenteric vein
  • Any arterial reconstruction at the time of surgery
  • Age < 18years
  • Pregnancy
  • PD for chronic pancreatitis
  • PD for pancreatic trauma
  • PD for post-ERCP complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712971

Locations
Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Baki Topal
Investigators
Study Director: Baki Topal, MD, PhD University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01712971     History of Changes
Other Study ID Numbers: LPD
Study First Received: October 18, 2012
Last Updated: September 16, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Gasthuisberg:
surgery
pancreas
tumour
blood loss

Additional relevant MeSH terms:
Neoplasms
Hemorrhage
Pancreatic Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014