Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer

NCT04842968 | Completed

• 1 other identifier: IV/3228/2021-EKU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Nodal staging holds both important prognostic and predictive value at colorectal cancer. Regional lymph nodes are located close to the primary tumor in the mesocolon / mesorectum. Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging "accuracy" criteria. In order to reach this number of lymph nodes, a precise surgical technique (total mesorectal excision or complete mesocolic excision), as well as a thorough pathological specimen work-up is needed. The aim of the study is to investigate, if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist, hence leading to a better staging and hopefully even to a better outcome in the long run. In 2014-2015 two surgical centers randomised resected colorectal specimens in 1:1 ratio to methylene-blue injection arm and control (no injection) arm in a total of 200 consecutive cases. Both pathologic and oncologic treatment were led regardless of the injection, reports were just routinely saved in the routine medical documentation. This retrospective study is designed to recall patient-related, surgery-related factors, as well as pathology reports including nodal staging from the medical databases. The investigators aim to find correlation between methylene blue "staining" and lymph node yield. In addition, the investigators plan to crossmatch methylene blue injection, as a process, with long term survival of the patients.

Conditions

Lymph Node Metastases; Colorectal Cancer

Keywords

colorectal; cancer; lymph; node; metastasis; methylene-blue

Outcome Measures

Primary Outcomes (4)

• Total number of lymph nodes

  Total number of lymph nodes examined by pathologist

  Within 4 weeks after operation (at pathology work-up)

• Positive lymph nodes

  Number of positive lymph nodes found by pathologist

  Within 4 weeks after operation (at pathology work-up)

• Nodal staging accuracy

  Minimum Nr of 12 lymph nodes examined if reported N stage is N0, or positive lymph node=s) found

  Within 4 weeks after operation (at pathology work-up)

• At least 12 lymph nodes harvested

  Minimum Nr of 12 lymph nodes examined by pathologist

  Within 4 weeks after operation (at pathology work-up)

Secondary Outcomes (1)

• Overall survival

  5 years (60 months) after operation

Study Arms (2)

Methylene blue

EXPERIMENTAL

Methylene blue solution (50 mg in 30 ml of saline solution) was injected in the cannulated main supplying artery of the freshly removed specimen, ex vivo. Colorectal specimen was then processed in the routine pathological work-up way.

Other: Methylene blue injection

Control

NO INTERVENTION

Colorectal specimens were processed in the routine pathological work-up way.

Interventions

Methylene blue injection OTHER

Methylene blue solution is injected ex vivo in the main supplying artery trunk of the freshly removed colorectal specimen. (50 mg in 30 ml saline)

Methylene blue

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective operation.
• Colon or rectum resection performed.
• Malignant colorectal condition.
• Curative intent.

You may not qualify if:

• Acute surgery performed
• Final histology: benign
• No other pathologic method (apart form Methylene Blue injection) used to improve lymph node yield

Sponsors & Collaborators

• St. Borbala Hospital: lead

Study Sites (1)

St. Borbala Hospital

Tatabánya, 2800, Hungary

Location

MeSH Terms

Conditions

Lymphatic Metastasis; Colorectal Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Balazs Banky, PhD

  St. Borbala Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Five to six years ago specimens from a total fo 200 consecutive colorectal cancer resection cases were randomized into two groups: 1. main supplying artery was cannulated and injected with methylene blue solution, 2. no intervention, routine specimen handling.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 13, 2021
• Study Start: April 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: September 15, 2021
• Last Updated: December 2, 2024

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)