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

NCT ID: NCT06119867

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2025-12-01

Brief 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.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Japanese pathological investigation

Intervention Type: PROCEDURE

Japanese pathological investigation

European pathological investigation method group

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

Group Type: ACTIVE_COMPARATOR

European pathological investigation

Intervention Type: PROCEDURE

The European pathology evaluation method involves the analysis of fresh and intact specimens. Pathologists carefully inspect the entire specimen's appearance and assess the surgical resection plane and capture complete photographs for documentation purposes before further sectioning the specimen. During specimen processing, the CRM is initially marked with ink or other markers. After fixation, macroscopic data are recorded, and the entire length of the intestine is cut into cross-sections at intervals of 3-4 millimeters. These sections are then undergoing subsequent systematic pathological examination. However, the surgeon will be involved in the Japanese pathological investigation method. Intraoperative markings will be made 10 cm bilaterally from the primary tumor area. The resected colon will be incised at 1 cm intervals, after which the pericolic lymph nodes will be harvested. Each single retrieved lymph node will be packed up independently and will be examined by the pathologist.

Interventions

Japanese pathological investigation

Japanese pathological investigation

Intervention Type: PROCEDURE

European pathological investigation

The European pathology evaluation method involves the analysis of fresh and intact specimens. Pathologists carefully inspect the entire specimen's appearance and assess the surgical resection plane and capture complete photographs for documentation purposes before further sectioning the specimen. During specimen processing, the CRM is initially marked with ink or other markers. After fixation, macroscopic data are recorded, and the entire length of the intestine is cut into cross-sections at intervals of 3-4 millimeters. These sections are then undergoing subsequent systematic pathological examination. However, the surgeon will be involved in the Japanese pathological investigation method. Intraoperative markings will be made 10 cm bilaterally from the primary tumor area. The resected colon will be incised at 1 cm intervals, after which the pericolic lymph nodes will be harvested. Each single retrieved lymph node will be packed up independently and will be examined by the pathologist.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Society of Colorectal Surgeons

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Balaban

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir Balaban

Role: PRINCIPAL_INVESTIGATOR

Sechenov University

Petr Tsarkov

Role: STUDY_DIRECTOR

Sechenov University

Locations

Clinic of coloproctology and minimally invasive surgery

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Mingze He

Role: CONTACT

hemingze97@gmail.com

+79801881266

Facility Contacts

Mingze He

Role: primary

hemingze97@gmail.com

+79801881266

Vladimir Balaban

Role: backup

balaban@kkmx.ru

+79889478358

Other Identifiers

0004

Identifier Type: -

Identifier Source: org_study_id