NCT00906802

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%.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

7 years

First QC Date

May 19, 2009

Last Update Submit

July 22, 2009

Conditions

Pancreatic Cancer

Keywords

pancreaticoduodenectomyreconstruction

Outcome Measures

Primary Outcomes (1)

  • the incidence of DGE

    3-6 months

Secondary Outcomes (1)

  • the incidence of other complication associated with reconstruction

    3-6 months

Study Arms (2)

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

R-Y reconstructionPROCEDURE

The reconstruction was performed by R-Y anastomosis.

Also known as: the cutting R-Y anastmosis
R-Y reconstruction

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Kazuhiro Hanazaki, Prof

    Kochi University

    STUDY CHAIR

Central Study Contacts

Takehiro Okabayashi, MD, PhD

CONTACT

81-88-880-2370tokabaya@kochi-u.ac.jp

Kazuhiro Hanazaki, Prof

CONTACT

81-88-880-2370im31@kochi-u.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

April 1, 2003

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

JP(1)