The Effects of Gastric Tube on the Quality of Life and Nu... | NCT01361750

Studies
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy

NCT01361750

Sponsor

Peking University

Status

Terminated

Last Update Posted

Mar 31, 2020Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Oesophageal Cancer

Interventions

gastric tube

Countries

China

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

higher occurrence of complication than expected for both groups

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

May 24, 2011

First Submission Date that Met QC Criteria

May 26, 2011

First Posted Date

May 27, 2011Estimated

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

Mar 29, 2020

Last Update Posted Date

Mar 31, 2020Actual

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

This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.

Detailed Description

Not provided

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gastirc tube group	Experimental	conduit will be perfomed by narrowed gastric tube	Procedure: gastric tube
control group	No Intervention	conduit will be traditional subtotal stomach without any surgical modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gastric tube	Procedure	the stomach will be cut into a narrowed tube-shape conduit	gastirc tube group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of nutritional status and quality of life before and after operation		before operation (baseline), 1 month, 6 month and 12 month after operation

Secondary Outcomes

Measure	Description	Time Frame
change of serum markers and tissue inflammatory status before and after operation		before operation (baseline), 1 month, 6 month and 12 month after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

esophageal cancer (squamous and adenocarcinoma subtypes)
eligble for Ivor-Lowis esophagectomy
expected survival time longer than 12 months

Exclusion Criteria:

palliative resection(non-R0)
anastomosis leak
jejunum or colon transversum interponate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yue Yang, M.D.	Peking University Health Science Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University School of Oncology		Beijing	Beijing Municipality	100142	China

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided