Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision (RLF)

August 3, 2021 updated by: Walter Brunner

Background: An exact lymph node staging is essential in the treatment of rectal cancer.

Objective: The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision (taTME).

Design: This is a retrospective, non-randomised study. Settings: This study was conducted at a tertiary hospital by a multidisciplinary team.

Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were analysed. Patients with indigo carmine injection (intervention group) were compared to those without (control group).

Interventions: Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection.

Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary outcome measure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Rorschach, Switzerland, 9400
        • Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing elective, oncologic rectum resection in TaTME technique

Description

Inclusion Criteria:

  • elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.

Exclusion Criteria:

  • abdominoperineal resection
  • extended colon resection
  • previous surgery of the rectum, the left colon or the mesocolon/-rectum
  • patients rejecting retrospective data analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with indigo carmine stained specimen
Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.
Other: injection of indigo carmine
Ex vivo intra-arterial injection of 20 ml indigo carmine solution (10mL, 0.4% indigo carmine with 10mL, 0.9% saline solution) in the transanal total mesorectal excision specimen via the inferior mesenteric artery.
Patients with unstained specimen
Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retrieved lymph nodes
Time Frame: 1 - 7 days after surgery
number of lymph nodes retrieved by pathologist from the specimen
1 - 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 5 years
overall survival
5 years
positive lymph nodes
Time Frame: 1 - 7 days after surgery
number of lymph nodes with microscopic tumor infiltration
1 - 7 days after surgery
N stage
Time Frame: 1 - 7 days after surgery
N stage according TNM version 7
1 - 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Brunner

Investigators

  • Principal Investigator: Walter Brunner, MD MSc MBA, Kantonsspital St. Gallen, Rorschach branch, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chir202001
  • 2020-01324 (Other Identifier: Swissethics BASEC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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