Multivisceral Resections for Locally Advanced Gastric Cancer | NCT06103435

Studies
Multivisceral Resections for Locally Advanced Gastric Cancer

NCT06103435

Sponsor

Jagiellonian University

Status

Completed

Last Update Posted

Oct 26, 2023Actual

Enrollment

1,476Actual

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Extent od surgical resection

Countries

Poland

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

Oct 2023

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

Jan 1996Actual

Primary Completion Date

Dec 2020Actual

Completion Date

Dec 2020Actual

First Submitted Date

Oct 18, 2023

First Submission Date that Met QC Criteria

Oct 25, 2023

First Posted Date

Oct 26, 2023Actual

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

Oct 25, 2023

Last Update Posted Date

Oct 26, 2023Actual

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

The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:

Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications
What factors affect prognosis of patients with locally advanced gastric cancer

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

1,476Actual

Name	Type	Description	Arm Group Labels	Other Names
Extent od surgical resection	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications	Type and severity of complications graded by Clavien-Dindo scoring system (from 0 to 5, higher scores mean worse outcome)	up to 90 days
Survival	Overall survival	Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of reoperations	Reoperations	up to 90 days
Length of postoperative hospital stay	Hospital stay	Up to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gastric adenocarcinoma
intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0)
partial or total gastrectomy

Exclusion Criteria:

distant metastases (M1)
gastrectomy combined with resection of organs other than spleen, pancreas, or colon

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with resectable gastric cancer treated between January 1996 and December 2020 in the First Department of Surgery, Jagiellonian University Medical College

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marek Sierżęga, MD, PhD	Jagiellonian University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Department of Surgery, Jagiellonian University Medical College		Krakow	Małopolska	30-688	Poland

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