Prospective Observational Study Comparing the Use of Circ... | NCT05007912

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

NCT05007912

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Aug 17, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Stomach Neoplasm

Interventions

Esophagojejunostomy type

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2021Actual

Primary Completion Date

Jun 21, 2023Estimated

Completion Date

Jun 21, 2023Estimated

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 9, 2021

First Posted Date

Aug 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2021

Last Update Posted Date

Aug 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyung-Ho Kim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Esophagojejunostomy type	Procedure	Use of either circular or linear stapler	Linear Group Orvil Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Gastric cancer patients involving the upper stomach

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
So Hyun Kang	Contact	+82-31-787-7099		shkang@snubh.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided