Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|