Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Kochi University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kochi University
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00906802
First received: May 19, 2009
Last updated: July 22, 2009
Last verified: July 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 19, 2009 | ||||||||
| Last Updated Date | July 22, 2009 | ||||||||
| Start Date ICMJE | April 2003 | ||||||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
the incidence of DGE [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
the incidence of DGE [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT00906802 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
the incidence of other complication associated with reconstruction [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy | ||||||||
| Official Title ICMJE | Benefit of R-Y Reconstruction After Pancreaticoduodenectomy | ||||||||
| Brief Summary | One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%. |
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| Detailed Description | We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Pancreatic Cancer | ||||||||
| Intervention ICMJE | Procedure: R-Y reconstruction
The reconstruction was performed by R-Y anastomosis.
Other Name: the cutting R-Y anastmosis |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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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 | 40 | ||||||||
| Estimated Completion Date | April 2010 | ||||||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00906802 | ||||||||
| Other Study ID Numbers ICMJE | RPD Study | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Kochi Medical School, Kochi University | ||||||||
| Study Sponsor ICMJE | Kochi University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Kochi University | ||||||||
| Verification Date | July 2009 | ||||||||
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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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