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

• Conditions: Stomach Neoplasm
• Interventions: Procedure: Esophagojejunostomy type

• Registration Number: NCT05007912
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Status Verified: 2021-08
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-09
• Last Update Submitted: 2021-08-09
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orvil Group	Esophagojejunostomy type	Group that used the Orvil (circular stapler) for esophagojejunostomy
Linear Group	Esophagojejunostomy type	Group that used the linear stapler for esophagojejunostomy

Primary Outcome Measures

Name	Time	Method
Anastomosis complication	within 1 year	including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of