NCT01361750

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

May 24, 2011

Last Update Submit

March 29, 2020

Conditions

Oesophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • change of serum markers and tissue inflammatory status before and after operation

    before operation (baseline), 1 month, 6 month and 12 month after operation

Study Arms (2)

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

gastric tubePROCEDURE

the stomach will be cut into a narrowed tube-shape conduit

gastirc tube group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University School of Oncology

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Yue Yang, M.D.

    Peking University Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thoracic Surgery II

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 27, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

CN(1)