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
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00906802
First received: May 19, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kochi Medical School, Kochi University
ClinicalTrials.gov 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:
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

ClinicalTrials.gov processed this record on August 28, 2014