NCT03632395

Brief Summary

Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

May 21, 2020

Status Verified

August 1, 2018

Enrollment Period

2.6 years

First QC Date

August 13, 2018

Last Update Submit

May 20, 2020

Conditions

Anastomotic Leak

Keywords

gastric cancerpostoperative complicationanastomotic leakoral contrast agentcomputed tomography

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of anastomotic leak

    CT was routinely used to detect early anastomotic leak after gastric cancer surgery

    5-10 days after surgery

Interventions

computed tomographyDIAGNOSTIC_TEST

computed tomography

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent gastric cancer surgery.

You may qualify if:

  • Patients with gastric cancer surgery

You may not qualify if:

  • Patients with non gastric cancer surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Anastomotic LeakStomach NeoplasmsPostoperative Complications

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • BIRENDRA K SAH, Ph D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

November 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 21, 2020

Record last verified: 2018-08

Locations

CN(1)