Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
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Purpose
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
| Condition | Intervention |
|---|---|
|
Pancreas Cancer Fistula |
Procedure: stent Procedure: Distal pancreatectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail |
- Drain fluid content analyses [ Time Frame: At least 5 postoperative days ] [ Designated as safety issue: Yes ]Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
- Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent [ Time Frame: At least 5 postoperative days ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Stent |
Procedure: stent
ERCP guided stent insertion before transection of the gland
Other Name: ERCP
|
| Active Comparator: conventional distal pancreatectomy |
Procedure: Distal pancreatectomy
conventional distal pancreatectomy
Other Name: surgery
|
Detailed Description:
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
Exclusion Criteria:
- The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.
Contacts and Locations| Sweden | |
| Karolinksa university hospital | |
| Stockholm, Sweden, 14186 | |
| Study Director: | Urban Arnelo | Karolinksa university hospital |
| Principal Investigator: | Farshad Frozanpor | Karolinksa university hospital |
| Study Chair: | Lars Lundell, Professor | Karolinska Institutet |
More Information
No publications provided by Karolinska Institutet
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Karoliska instuitut, Farshad Frozanpor |
| ClinicalTrials.gov Identifier: | NCT00500968 History of Changes |
| Other Study ID Numbers: | 2006/3:3 |
| Study First Received: | July 12, 2007 |
| Last Updated: | April 6, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
Pancreas Leakage Fistula tail |
Additional relevant MeSH terms:
|
Fistula Pancreatic Neoplasms Pathological Conditions, Anatomical Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms |
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013