Trial Outcomes & Findings for Lymphatic Mapping for Sentinel Node Identification and Analysis (NCT NCT01662752)

Last Updated: 2019-08-09

Results Overview

To establish whether it is possible to identify the first order draining mesocolic lymph nodes (sentinel lymph node(s) (SLNs) in patients with suspected T1 and T2 colonic cancer, using Indocyanine Green (ICG), a fluorescent mapping agent, and a laparoscopic near infrared imaging (NIR) system

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

28 days

Results posted on

2019-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Indocyanine Green Single inject a fluorescent dye (indocyanine green) adjacent to the tumour. The dye will then be seen as it fluoresces in the light form the near infrared spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected around the tumour. The mesentery in which the lymph nodes draining the tumour are located will then be examined by laparoscopy as it is expected that fluorescence will be identified within approximately 5 minutes of the injection.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lymphatic Mapping for Sentinel Node Identification and Analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indocyanine Green n=30 Participants Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging Indocyanine green: Please see arm description
Age, Continuous	66 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United Kingdom	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Indocyanine Green n=30 Participants Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging Indocyanine green: Please see arm description
Subjects in Which the SLN(s) Are Identified	27 Participants

SECONDARY outcome

Timeframe: 28 days

Population: There were 10 patients with positive nodes hence this is the denominator for the sensitivity analysis. There were 20 patients with negative lymph nodes overall hence this is the denominator for the specificity analysis.

To assess the extent to which that the tumour-bearing status of SLN(s) identified corresponds with lymph node status as assessed by standard methods (pathological examination of excised nodes using H\&E and immunohistochemistry)

Outcome measures

Outcome measures
Measure	Indocyanine Green n=30 Participants Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging Indocyanine green: Please see arm description
Sensitivity and Specificity of Tumour-bearing Status of SLN(s) as a Measure of Lymph Node Status When Assessed by Standard Techniques Sensitivity	3 Participants
Sensitivity and Specificity of Tumour-bearing Status of SLN(s) as a Measure of Lymph Node Status When Assessed by Standard Techniques Specificity	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

To estimate the proportion of patients with aberrant nodal drainage. i.e. the proportion with SLN(s) lying outside the standard resection field

Outcome measures

Outcome measures
Measure	Indocyanine Green n=30 Participants Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging Indocyanine green: Please see arm description
Frequency and Tumour-bearing Status of Aberrant SLN(s	0 Participants

Adverse Events

Indocyanine Green

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Indocyanine Green n=30 participants at risk Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging Indocyanine green: Please see arm description
Injury, poisoning and procedural complications Wound pain	96.7% 29/30 • 2 year
Gastrointestinal disorders Nausea	40.0% 12/30 • 2 year
Cardiac disorders Atrial fibrillation	3.3% 1/30 • 2 year
Cardiac disorders Dizziness	3.3% 1/30 • 2 year
Cardiac disorders Palpitations	3.3% 1/30 • 2 year
Cardiac disorders Paroxysmal atrial fibrillation	3.3% 1/30 • 2 year
Gastrointestinal disorders Bloating	6.7% 2/30 • 2 year
Gastrointestinal disorders Constipations	3.3% 1/30 • 2 year
Gastrointestinal disorders Distended abdomen	3.3% 1/30 • 2 year
Gastrointestinal disorders Epigastric pain	3.3% 1/30 • 2 year
Gastrointestinal disorders Hiccough	3.3% 1/30 • 2 year
Gastrointestinal disorders Ileus	13.3% 4/30 • 2 year
Gastrointestinal disorders Vomiting	10.0% 3/30 • 2 year
General disorders Febrile reaction	3.3% 1/30 • 2 year
General disorders Rigors	3.3% 1/30 • 2 year
Infections and infestations Urinary tract infection	6.7% 2/30 • 2 year
Injury, poisoning and procedural complications Postoperative ileus	3.3% 1/30 • 2 year
Investigations Low haemoglobin	3.3% 1/30 • 2 year
Musculoskeletal and connective tissue disorders Groin pain	3.3% 1/30 • 2 year
Nervous system disorders Tremor	3.3% 1/30 • 2 year
Psychiatric disorders Confusion	3.3% 1/30 • 2 year
Renal and urinary disorders Urinary retention	3.3% 1/30 • 2 year
Respiratory, thoracic and mediastinal disorders Atelectasis	3.3% 1/30 • 2 year
Vascular disorders Low blood pressure	3.3% 1/30 • 2 year

Additional Information

Professor Robin Kennedy

St Mark's Hospital

Phone: +44(0)2082354046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place