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NCT05007912 Clinical Trial

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

Stomach Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05007912
Other study ID # SNUBH_EJ
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 21, 2021
Est. completion date June 21, 2023

Study information
Verified date August 2021
Source Seoul National University Bundang Hospital
Contact So Hyun Kang
Phone +82-31-787-7099
Email shkang@snubh.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 21, 2023
Est. primary completion date June 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Esophagojejunostomy type
Use of either circular or linear stapler

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anastomosis complication including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy within 1 year
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