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Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

In general, the European pathological examination method primarily relies on pathologists and does not require the involvement of surgeons. The Japanese pathological evaluation approach, on the other hand, involves the intervention of surgeons, particularly in the extraction of lymph nodes from fresh specimens and the assessment of specimen quality. Given that the Japanese pathological assessment method lacks systematic evaluation and there is currently no literature clearly demonstrating its diagnostic accuracy, the main objective of this study is to verify whether the diagnostic accuracy of the Japanese pathological investigation method is inferior to that of the European pathological evaluation method.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients diagnosed with colon cancer who underwent colectomy;

• Patients with pathological confirmed adenocarcinoma;

• Patients agreed to participate in the study.

Locations
Other Locations
Russian Federation
Clinic of coloproctology and minimally invasive surgery
RECRUITING
Moscow
Contact Information
Primary
Mingze He
hemingze97@gmail.com
+79801881266
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 430
Treatments
Experimental: Japanese pathological investigation method group
The surgeon will be involved into the Japanese pathological investigation method. The surgeon will perform the intraoperative markings and the postoperative lymph node harvest, after which the specimen will be assessed by the pathologist.
Active_comparator: European pathological investigation method group
After receiving the resected specimen, the entire process will be independently managed by the pathologist.
Related Therapeutic Areas
Sponsors
Leads: Russian Society of Colorectal Surgeons

This content was sourced from clinicaltrials.gov