Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
|ClinicalTrials.gov Identifier: NCT01696903|
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Fistula||Procedure: Pancreaticojejunostomy technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
No Intervention: Conventional anastomosis
Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell'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.
- Clinically Relevant Postoperative Pancreatic Fistula [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]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 ]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 ]The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696903
|Department of Upper Abdominal Surgery, Linköping University Hospital|
|Linköping, Sweden, 58185|
|Department of Surgical gastroenterology, Karolinska University Hospital|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Christoph Ansorge, MD, PhD||Karolinska Institutet|
|Study Director:||Ralf Segersvärd, MD, PhD||Karolinska Institutet|