NCT07064655

Brief Summary

This study is to collect and analyze the clinical information of patients who underwent reconstruction using conduits other than the stomach, such as the colon and small intestine, after esophagectomy. Currently, reconstruction after esophagectomy is mainly performed using the stomach, and there is very little information on reconstruction using the colon and small intestine. Therefore, this study aims to collect information on patients who underwent reconstruction using conduits other than the stomach, analyze the surgical performance, find clinical improvements, and build a foundation for future clinical quality improvement.

Trial Health

65
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Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
56mo left

Started Jul 2025

Longer than P75 for all trials

Status
not yet recruiting

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 Progress15%
Jul 2025Dec 2030

First Submitted

Initial submission to the registry

July 5, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2030

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

July 5, 2025

Last Update Submit

July 5, 2025

Conditions

Keywords

esophageal canceresophagectomynon-gastric conduit reconstruction

Outcome Measures

Primary Outcomes (2)

  • anastomotic leakage rate

    From enrollment to 6 months after esophagectomy

  • rate of conduit necrosis

    From enrollment to 6 months after esophagectomy

Study Arms (1)

Non-gastric conduit group

Patients who received the reconstruction other than a gastric conduit after esophagectomy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients registered at Samsung Medical Center

You may qualify if:

  • Patients who have voluntarily signed an informed consent form and are willing and able to complete all requirements of the study.
  • Age 20 years or older.
  • Patients who are scheduled for esophagectomy and reconstruction with a conduit other than a gastric conduit is planned.

You may not qualify if:

  • Patients who do not consent to participate in this study
  • The investigator determines that the patient should not participate in the study because the investigator believes that the patient will not be able to comply with the study procedures, requirements, and procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Seong Yong Park, M.D., Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, Ph.D, Department of Thoracic and Cardiovascular Surgery

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 15, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

June 15, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) from this study, because the consent form did not include provisions for data sharing and institutional policy does not permit it.