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
Information provided by:
Kochi University Identifier:
First received: May 19, 2009
Last updated: July 22, 2009
Last verified: July 2009
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 Intervention
Pancreatic Cancer
Procedure: R-Y reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Benefit of R-Y Reconstruction After Pancreaticoduodenectomy

Resource links provided by NLM:

Further study details as provided by Kochi University:

Primary Outcome Measures:
  • the incidence of DGE [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence of other complication associated with reconstruction [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00906802

Contact: Takehiro Okabayashi, MD, PhD 81-88-880-2370
Contact: Kazuhiro Hanazaki, Prof 81-88-880-2370

Kochi Medical School Recruiting
Nankoku, Kochi, Japan, 783-8505
Contact: Takehiro Okabayashi, MD, PhD    81-88-880-2370   
Contact: Kazuhiro Hanazaki, Prof    81-88-880-2370   
Sponsors and Collaborators
Kochi University
Study Chair: Kazuhiro Hanazaki, Prof Kochi University
  More Information

Responsible Party: Kochi Medical School, Kochi University Identifier: NCT00906802     History of Changes
Other Study ID Numbers: RPD Study 
Study First Received: May 19, 2009
Last Updated: July 22, 2009
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases processed this record on April 27, 2016