Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreati... | NCT00906802

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

NCT00906802

Sponsor

Kochi University

Status

Unknown status

Last Update Posted

Jul 23, 2009Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pancreatic Cancer

Interventions

R-Y reconstruction

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Apr 2010Estimated

Completion Date

Apr 2010Estimated

First Submitted Date

May 19, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2009

Last Update Posted Date

Jul 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R-Y reconstruction	Experimental	the reconstruction was performed by R-Y anastomosis	Procedure: R-Y reconstruction
conventional reconstruction	No Intervention	the anastomosis was performed by B-II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
R-Y reconstruction	Procedure	The reconstruction was performed by R-Y anastomosis.	R-Y reconstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of DGE		3-6 months

Secondary Outcomes

Measure	Description	Time Frame
the incidence of other complication associated with reconstruction		3-6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Takehiro Okabayashi, MD, PhD	Contact	81-88-880-2370		tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof	Contact	81-88-880-2370		im31@kochi-u.ac.jp

Overall Officials

Name	Affiliation	Role
Kazuhiro Hanazaki, Prof	Kochi University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kochi Medical School	Recruiting	Nankoku	Kochi	783-8505	Japan

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided