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OpenTrials
Completed

NCT Number: NCT06103435

Multivisceral Resections for Locally Advanced Gastric Cancer

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

First Department of Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extent od surgical resection

Procedure

Primary outcomes

  1. 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)

  2. Survival

    Time frame: Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months

    Overall survival

Secondary outcomes

  1. Rate of reoperations

    Time frame: up to 90 days

    Reoperations

  2. Length of postoperative hospital stay

    Time frame: Up to 6 months

    Hospital stay

  3. Rate of readmissions

    Time frame: One year from surgery

    Readmission

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Acronym: TOCCATA

Important dates

Study start
1996
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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