Dumping Syndrome and Quality of Life After Vagus Nerve-pr... | NCT03880747

Studies
Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy

NCT03880747

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Mar 9, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Stomach Neoplasm

Interventions

Vagus nerve-preserving distal gastrectomy

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2017Actual

Primary Completion Date

Aug 19, 2019Actual

Completion Date

Aug 20, 2020Actual

First Submitted Date

Mar 17, 2019

First Submission Date that Met QC Criteria

Mar 17, 2019

First Posted Date

Mar 19, 2019Actual

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

Mar 7, 2021

Last Update Posted Date

Mar 9, 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

There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).

Detailed Description

The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vagus nerve preserving group		Patients who underwent vagus nerve-preserving distal gastrectomy for early gastric cancer	Procedure: Vagus nerve-preserving distal gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vagus nerve-preserving distal gastrectomy	Procedure	Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.	Vagus nerve preserving group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dumping syndrome	Sigstad score of equal or more than 7	1 year

Secondary Outcomes

Measure	Description	Time Frame
EORTC C-30/STO22	Quality of life surveys	3 months, 6 months, 1 year
Postoperative complication	incidence of postoperative complication

Other Outcomes

Measure	Description	Time Frame
Operative time	Time of operation	Immediately after operation
Estimated blood loss	Blood loss during operation	Immediately after operation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy

Exclusion Criteria:

Sacrificed vagus nerve
Anastomosis other than Roux-en Y gastrojejunostomy or uncut Roux-en Y gastrojejunostomy
conversion to an open procedure
combined resection of other organs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

There is currently no plan to share our IPD with other researchers unless needed.

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

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Browse Branches

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