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

NCT04455737 | Completed

• 2 other identifiers: Chir2020012020-01324
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Neoplasms

Keywords

indigo carmine; lymph node; pathology

Outcome Measures

Primary Outcomes (1)

• retrieved lymph nodes

  number of lymph nodes retrieved by pathologist from the specimen

  1 - 7 days after surgery

Secondary Outcomes (3)

• positive lymph nodes

  1 - 7 days after surgery

• N stage

  1 - 7 days after surgery

• survival

  5 years

Study Arms (2)

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

Patients with unstained specimen

Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.

Interventions

injection of indigo carmine OTHER

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 indigo carmine stained specimen

Eligibility Criteria

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

Study Population

Patients undergoing elective, oncologic rectum resection in TaTME technique

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Walter Brunner: lead

Study Sites (1)

Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

Rorschach, 9400, Switzerland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Walter Brunner, MD MSc MBA

  Kantonsspital St. Gallen, Rorschach branch, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: October 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)