Rectal NeoplasmsRLFNCT04455737
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
An observational study of Rectal Neoplasms, run by Walter Brunner at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- injection of indigo carmine
- Type of treatment
- Injection or infusion
- How many people
- 189 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective, oncologic rectum resection in TaTME technique
Who may be able to join
- elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.
Who cannot join
- abdominoperineal resection
- extended colon resection
- previous surgery of the rectum, the left colon or the mesocolon/-rectum
- patients rejecting retrospective data analysis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Rorschach, 9400
About this study
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).
Read more
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
- Being tested
- injection of indigo carmine
- Keywords
- indigo carmine, lymph node, pathology
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of indigo carmineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: injection of indigo carmine | |
| Patients with unstained specimen | Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
retrieved lymph nodes
number of lymph nodes retrieved by pathologist from the specimen
Measured: 1 - 7 days after surgery
Secondary outcomes (3)
positive lymph nodes
number of lymph nodes with microscopic tumor infiltration
Measured: 1 - 7 days after surgery
N stage
N stage according TNM version 7
Measured: 1 - 7 days after surgery
survival
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study startOct 2013
- Primary completionDec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Brunner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walter Brunner, Cantonal Hospital of St. Gallen
- Investigators
- Walter Brunner, MD MSc MBA, Principal investigator, Kantonsspital St. Gallen, Rorschach branch, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455737
- Sponsor's protocol ID
- Chir202001
- Other IDs
- 2020-01324
- Acronym
- RLF
- Status last verified
- Aug 2021
- First submitted
- 29 Jun 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
- ClinicalTrials.gov ID
- NCT04455737
- Acronym / sponsor ID
- RLF / Chir202001
- Conditions
- Rectal Neoplasms
- Keywords
- indigo carmine, lymph node, pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Walter BrunnerUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with indigo carmine stained specimen | – | Other: injection of indigo carmineSpecimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision. |
| Patients with unstained specimen | – | –Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective, oncologic rectum resection in TaTME technique
Key inclusion criteria (1 listed)
- elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.
Key exclusion criteria (4 listed)
- abdominoperineal resection
- extended colon resection
- previous surgery of the rectum, the left colon or the mesocolon/-rectum
- patients rejecting retrospective data analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of indigo carmineEx 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. | Other | Patients with indigo carmine stained specimen |
Primary outcome
retrieved lymph nodes
Time frame: 1 - 7 days after surgery
number of lymph nodes retrieved by pathologist from the specimen
3 secondary outcomes
positive lymph nodes
Time frame: 1 - 7 days after surgery
N stage
Time frame: 1 - 7 days after surgery
survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Brunner, MD MSc MBA principal investigator
Kantonsspital St. Gallen, Rorschach branch, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Walter Brunner at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retrieved lymph nodes (time frame: 1 - 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.