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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 25, 2012 | ||||||||
| Last Updated Date | September 26, 2012 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01696903 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
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. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Investigation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With High Risk for Postoperative Pancreatic Fistula | ||||||||
| Official Title ICMJE | Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Pancreaticojejunostomy technique | ||||||||
| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | September 2015 | ||||||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01696903 | ||||||||
| Other Study ID Numbers ICMJE | SKARV-GLH-001, KI-DSGE-DUAS | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christoph Ansorge, Karolinska Institutet | ||||||||
| Study Sponsor ICMJE | Karolinska Institutet | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Karolinska Institutet | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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