Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula|
- Clinically Relevant Postoperative Pancreatic Fistula [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula
- Associated postoperative morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.
- Severity of postoperative complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
No Intervention: Conventional anastomosis
Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattel's duct-to-mucosa technique".
Active Comparator: Novel anastomosis
Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.
Procedure: Pancreaticojejunostomy technique
The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.
Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696903
|Contact: Christoph Ansorge, MD, PhDemail@example.com|
|Contact: Ralf Segersvärd, MD, PhDfirstname.lastname@example.org|
|Department of Upper Abdominal Surgery, Linköping University Hospital||Recruiting|
|Linköping, Sweden, 58185|
|Contact: Thomas Gasslander, MD, PhD email@example.com|
|Principal Investigator: Thomas Gasslander, MD, PhD|
|Sub-Investigator: Bergthor Björnsson, MD|
|Department of Surgical gastroenterology, Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 14186|
|Contact: Christoph Ansorge, MD firstname.lastname@example.org|
|Contact: Ralf Segersvärd, MD, PhD email@example.com|
|Principal Investigator: Christoph Ansorge, MD, PhD|
|Sub-Investigator: John Blomberg, MD, PhD|
|Principal Investigator:||Christoph Ansorge, MD, PhD||Karolinska Institutet|
|Study Director:||Ralf Segersvärd, MD, PhD||Karolinska Institutet|