Investigation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With High Risk for Postoperative Pancreatic Fistula
This study is currently recruiting participants.
Verified September 2012 by Karolinska Institutet
Sponsor:
Karolinska Institutet
Collaborators:
University Hospital, Linkoeping
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Christoph Ansorge, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01696903
First received: September 25, 2012
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postoperative Pancreatic Fistula Pancreatic Texture Pancreatic Duct Diameter Pancreatic Consistency Pancreaticoduodenectomy |
Procedure: Pancreaticojejunostomy technique |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Karolinska Institutet:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
Other Outcome Measures:
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Conventional anastomosis
The pancreaticojejunostomy is carried out in a traditional way according to "Cattel's duct-to-mucosa technique".
|
Procedure: Pancreaticojejunostomy technique |
|
Active Comparator: Novel anastomosis
A new technique is used for the reconstruction of the pancreaticojejunostomy. The pancreas is intubated into the jejunum.
|
Procedure: Pancreaticojejunostomy technique |
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients scheduled for elective pancreaticoduodenectomy
- Pancreatic gland with high risk criteria for associated postoperative morbidity
Exclusion Criteria:
- Patients do not accept participation
- Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696903
Contacts
| Contact: Christoph Ansorge, MD | +46734098881 | christoph.ansorge@karolinska.se |
| Contact: Ralf Segersvärd, MD, PhD | ralf.segersvard@ki.se |
Locations
| Sweden | |
| Department of Upper GI Surgery, Sahlgrenska University Hospital | Recruiting |
| Göteborg, Sweden, 41345 | |
| Contact: Anders Thune, MD, PhD anders.thune@vgregion.se | |
| Principal Investigator: Anders Thune, MD, PhD | |
| Department of Upper Abdominal Surgery, Linköping University Hospital | Recruiting |
| Linköping, Sweden, 58185 | |
| Contact: Thomas Gasslander, MD, PhD thomas.gasslander@liu.se | |
| Principal Investigator: Thomas Gasslander, MD, PhD | |
| Department of Surgical gastroenterology, Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 14186 | |
| Contact: Christoph Ansorge, MD christoph.ansorge@karolinska.se | |
| Contact: Ralf Segersvärd, MD, PhD ralf.segersvard@ki.se | |
| Principal Investigator: Ralf Segersvard, MD, PhD | |
| Sub-Investigator: Christoph Ansorge, MD | |
Sponsors and Collaborators
Karolinska Institutet
University Hospital, Linkoeping
Sahlgrenska University Hospital, Sweden
Investigators
| Principal Investigator: | Ralf Segersvärd, MD, PhD | Karolinska Institutet |
More Information
Additional Information:
Publications:
| Responsible Party: | Christoph Ansorge, Ralf Segersvärd, MD, PhD, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01696903 History of Changes |
| Other Study ID Numbers: | SKARV-GLH-001, KI-DSGE-DUAS |
| Study First Received: | September 25, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | Sweden: National Board of Health and Welfare |
Keywords provided by Karolinska Institutet:
|
Postoperative pancreatic fistula Pancreatic texture Pancreatic duct diameter Pancreatic consistency Pancreaticoduodenectomy |
Additional relevant MeSH terms:
|
Fistula Pancreatic Fistula Pathological Conditions, Anatomical |
Digestive System Fistula Digestive System Diseases Pancreatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013