Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy

August 9, 2021 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital

Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy.

Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gastric cancer patients involving the upper stomach

Description

Inclusion Criteria:

  • Diagnosed as gastric adenocarcinoma
  • Involving the esophagogastric junction or gastric cardia
  • Age 18 - 80 years
  • Anticipated to undergo laparoscopic total or proximal gastrectomy
  • cT1-T4a

Exclusion Criteria:

  • Previous history of gastrectomy
  • Neoadjuvant chemotherapy or radiotherapy for gastric cancer
  • Invasion to other organs
  • Open conversion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orvil Group
Group that used the Orvil (circular stapler) for esophagojejunostomy
Procedure: Esophagojejunostomy type
Use of either circular or linear stapler
Linear Group
Group that used the linear stapler for esophagojejunostomy
Procedure: Esophagojejunostomy type
Use of either circular or linear stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomosis complication
Time Frame: within 1 year
including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy
within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2021

Primary Completion (Anticipated)

June 21, 2023

Study Completion (Anticipated)

June 21, 2023

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_EJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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