NCT05007912

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

June 21, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 9, 2021

Last Update Submit

August 9, 2021

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Anastomosis complication

    including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy

    within 1 year

Study Arms (2)

Orvil Group

Group that used the Orvil (circular stapler) for esophagojejunostomy

Procedure: Esophagojejunostomy type

Linear Group

Group that used the linear stapler for esophagojejunostomy

Procedure: Esophagojejunostomy type

Interventions

Esophagojejunostomy typePROCEDURE

Use of either circular or linear stapler

Linear GroupOrvil Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gastric cancer patients involving the upper stomach

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

So Hyun Kang

CONTACT

+82-31-787-7099shkang@snubh.org

Study Design

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

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 17, 2021

Study Start

June 21, 2021

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)