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

NCT01712971 | Withdrawn

• 1 other identifier: LPD
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Pancreatic Tumour; Peri-ampullary Tumour; Blood Loss

Keywords

surgery; pancreas; tumour; blood loss

Outcome Measures

Primary Outcomes (1)

• intra-operative blood loss

  the amount of intra-operative blood loss (ml) at the end of surgery (d0)

  day 0 (at the end of surgery)

Secondary Outcomes (3)

• Surgical resection margin

  day 30

• length of hospital stay after surgery

  day 30; 60; 90; 180

• hospital costs

  year 1 & 2

Study Arms (2)

OPD

standard open pancreaticoduodenectomy

LPD

laparoscopic pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from pancreatic or peri-ampullary tumour

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baki Topal: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Hemorrhage; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baki Topal, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 24, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

BE (1)