CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)

Russian Society of Colorectal Surgeons

Status and phase: Enrolling; Phase 3

Conditions: Colonic Neoplasms

Treatments: Procedure: Japanese pathological investigation; Procedure: European pathological investigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06119867

0004

Details and patient eligibility

About

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.

Enrollment: 430 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with colon cancer who underwent colectomy;
• Patients with pathological confirmed adenocarcinoma;
• Patients agreed to participate in the study.

Exclusion criteria

• Patients suffered from rectal cancer;
• Patients diagnosed with colon cancer but did not undergo colectomy;
• Patients refused participation.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

430 participants in 2 patient groups

Japanese pathological investigation method group

Experimental group

Description:

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.

Treatment:

Procedure: Japanese pathological investigation

European pathological investigation method group

Active Comparator group

Description:

After receiving the resected specimen, the entire process will be independently managed by the pathologist.

Treatment:

Procedure: European pathological investigation