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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRussian Society of Colorectal Surgeons

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with colon cancer who underwent colectomy;

Patients with pathological confirmed adenocarcinoma;

Patients agreed to participate in the study.

Disqualifiers

Patients suffered from rectal cancer;

Patients diagnosed with colon cancer but did not undergo colectomy;

Patients refused participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Japanese pathological investigation

    Procedure/Surgery

    Japanese pathological investigation

  • European pathological investigation

    Procedure/Surgery

    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.

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Japanese pathological investigation method groupExperimental treatment 1 intervention
Group B: European pathological investigation method groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.

indentification of the rate of postive lymph nodes

Time frame
up to 24 months

Secondary outcomes

1

The role of immunohistochemical examination in the Node (N) stage determination

indentification of the rate of postive lymph nodes using immunohistochemical examination

Time frame
up to 24 months
2

Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches

LNR=Postivie lymph node/ Total retrived lymph node

Time frame
up to 24 months
3

Comparison of the pT Stage between the European and Japanese pathological approaches

indentification of the rate of the pathological T stages

Time frame
up to 24 months
4

Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches

indentification of the rate of the postive proximal, distal or circular resection margin

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

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