Multivisceral Resections for Locally Advanced Gastric Cancer (TOCCATA)

October 25, 2023 updated by: Marek Sierzega, Jagiellonian University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Małopolska
      • Kraków, Małopolska, Poland, 30-688
        • First Department of Surgery, Jagiellonian University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: up to 90 days
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
Time Frame: Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months
Overall survival
Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of reoperations
Time Frame: up to 90 days
Reoperations
up to 90 days
Length of postoperative hospital stay
Time Frame: Up to 6 months
Hospital stay
Up to 6 months
Rate of readmissions
Time Frame: One year from surgery
Readmission
One year from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Marek Sierżęga, MD, PhD, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1996

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC_MVR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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