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Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy

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ClinicalTrials.gov Identifier: NCT00906802
Recruitment Status : Unknown
Verified July 2009 by Kochi University.
Recruitment status was:  Recruiting
First Posted : May 21, 2009
Last Update Posted : July 23, 2009
Sponsor:
Information provided by:
Kochi University

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%.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: R-Y reconstruction Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Benefit of R-Y Reconstruction After Pancreaticoduodenectomy
Study Start Date : April 2003
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: R-Y reconstruction
the reconstruction was performed by R-Y anastomosis
Procedure: R-Y reconstruction
The reconstruction was performed by R-Y anastomosis.
Other Name: the cutting R-Y anastmosis
No Intervention: conventional reconstruction
the anastomosis was performed by B-II



Primary Outcome Measures :
  1. the incidence of DGE [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. the incidence of other complication associated with reconstruction [ Time Frame: 3-6 months ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass

Exclusion Criteria:

  • A body weight loss greater than 10% during the six months prior to surgery
  • The presence of distant metastases
  • Seriously impaired function of vital organs due to respiratory, renal or heart disease

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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): NCT00906802


Contacts
Contact: Takehiro Okabayashi, MD, PhD 81-88-880-2370 tokabaya@kochi-u.ac.jp
Contact: Kazuhiro Hanazaki, Prof 81-88-880-2370 im31@kochi-u.ac.jp

Locations
Japan
Kochi Medical School Recruiting
Nankoku, Kochi, Japan, 783-8505
Contact: Takehiro Okabayashi, MD, PhD    81-88-880-2370    tokabaya@kochi-u.ac.jp   
Contact: Kazuhiro Hanazaki, Prof    81-88-880-2370    im31@kochi-u.ac.jp   
Sponsors and Collaborators
Kochi University
Investigators
Study Chair: Kazuhiro Hanazaki, Prof Kochi University

Responsible Party: Kochi Medical School, Kochi University
ClinicalTrials.gov Identifier: NCT00906802     History of Changes
Other Study ID Numbers: RPD Study
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009

Keywords provided by Kochi University:
pancreaticoduodenectomy
reconstruction

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases