Multivisceral Resections for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— TOCCATA  

Official title:

Multivisceral Resections for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103435
• Other study ID #: GC_MVR
• Status: Completed
• Start date: January 1996
• Est. completion date: December 2020

Study information

• Verified date: October 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1476
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Extent od surgical resection

Locations

Country	Name	City	State
Poland	First Department of Surgery, Jagiellonian University Medical College	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Survival	Overall survival	Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months
Secondary	Rate of reoperations	Reoperations	up to 90 days
Secondary	Length of postoperative hospital stay	Hospital stay	Up to 6 months
Secondary	Rate of readmissions	Readmission	One year from surgery