Trial Outcomes & Findings for Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer (NCT NCT02445456)
NCT ID: NCT02445456
Last Updated: 2022-07-06
Results Overview
Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
5 days after injection
Results posted on
2022-07-06
Participant Flow
Participant milestones
| Measure |
Ex-vivo
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
2
|
|
Overall Study
COMPLETED
|
13
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ex-vivo
n=13 Participants
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=2 Participants
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age category · < 50 years
|
2 Participants
n=13 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=15 Participants
|
|
Age, Customized
Age category · 51-60 years
|
5 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
5 Participants
n=15 Participants
|
|
Age, Customized
Age category · 61-70 years
|
6 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=15 Participants
|
|
Age, Customized
Age category · > 70 years
|
0 Participants
n=13 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants
|
2 Participants
n=2 Participants
|
12 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=13 Participants
|
2 participants
n=2 Participants
|
15 participants
n=15 Participants
|
|
Pre-operative tumour T stage
mrT1 - tumour confined to inner bowel wall
|
3 Participants
n=13 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=15 Participants
|
|
Pre-operative tumour T stage
mrT2 - tumour extending into muscle layer of the bowel wall
|
5 Participants
n=13 Participants
|
1 Participants
n=2 Participants
|
6 Participants
n=15 Participants
|
|
Pre-operative tumour T stage
mrT3 - tumour has grown into the outer lining of the bowel wall
|
5 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
5 Participants
n=15 Participants
|
|
Pre-operative N stage
mrN0 - no lymph nodes invaded by cancer cells
|
10 Participants
n=13 Participants
|
2 Participants
n=2 Participants
|
12 Participants
n=15 Participants
|
|
Pre-operative N stage
mrN1 - up to 3 nearby lymph nodes contain cancer cells
|
2 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=15 Participants
|
|
Pre-operative N stage
mrN2 - more than 3 lymph nodes contain cancer cells
|
1 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=15 Participants
|
|
Prior treatment
Nil
|
7 Participants
n=13 Participants
|
2 Participants
n=2 Participants
|
9 Participants
n=15 Participants
|
|
Prior treatment
Chemoradiation
|
3 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=15 Participants
|
|
Prior treatment
Local excision
|
3 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=15 Participants
|
|
Tumour diameter
|
3.0 centimeter
n=13 Participants
|
2.8 centimeter
n=2 Participants
|
3.0 centimeter
n=15 Participants
|
|
Tumour height above anal margin
|
7 centimeter
n=13 Participants
|
11 centimeter
n=2 Participants
|
8 centimeter
n=15 Participants
|
|
Tumour location
anterior
|
4 Participants
n=13 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=15 Participants
|
|
Tumour location
lateral
|
4 Participants
n=13 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=15 Participants
|
|
Tumour location
posterior
|
5 Participants
n=13 Participants
|
1 Participants
n=2 Participants
|
6 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 5 days after injectionAssess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection
Outcome measures
| Measure |
Ex-vivo
n=13 Participants
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=2 Participants
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Number of Participants Experiencing of Adverse or Hypersensitivity Reaction
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: at time of surgeryPopulation: Only patients who underwent surgery were analysed. Two patients in the ex-vivo group who were planned to have surgery did not proceed to surgery; instead they moved to a 'watch and wait' pathway after chemoradiation.
Assess frequency of Sienna+ tracer being detectable at the tumour injection site and in the lymph nodes at the time of surgery
Outcome measures
| Measure |
Ex-vivo
n=11 Operations
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=2 Operations
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Number of Operations Where Effects of Tracer Injection Can be Detected by Surgeon During Surgery
|
11 operations
|
2 operations
|
PRIMARY outcome
Timeframe: at time of surgeryPopulation: Only patients who underwent surgery were analysed. Two patients in the ex-vivo group who were planned to have surgery did not proceed to surgery; instead they moved to a 'watch and wait' pathway after chemoradiation.
Surgeon's qualitative assessment of any difficulties encountered during surgery which could be attributable to prior injection of the tracer, such as pigmentation or fibrosis making surgery more difficult than normal
Outcome measures
| Measure |
Ex-vivo
n=11 Operations
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=2 Operations
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Number of Operations Where There Was Any Surgical Difficulty Due to Tracer Injection Based on Qualitative Assessment by Surgeon
|
0 operations
|
0 operations
|
SECONDARY outcome
Timeframe: 5 days after surgeryPopulation: Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed.
The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe.
Outcome measures
| Measure |
Ex-vivo
n=11 Surgical mesorectal specimens
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=1 Surgical mesorectal specimens
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location
|
2 surgical mesorectal specimen
|
0 surgical mesorectal specimen
|
SECONDARY outcome
Timeframe: 5 days after surgeryPopulation: Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed.
A pathologist will identify the sentinel lymph node histologically and record whether this matches the location identified by the Sentimag probe which has been previously marked with a suture
Outcome measures
| Measure |
Ex-vivo
n=11 Surgical mesorectal specimens
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=1 Surgical mesorectal specimens
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node
|
2 surgical mesorectal specimen
|
0 surgical mesorectal specimen
|
SECONDARY outcome
Timeframe: MRI scan done 2 hours after Sienna+ tracer injectionPopulation: Only patients who had MRI scans done following tracer injection were included.
Evaluation of individual variability in Sienna+ distribution after endoscopic injection on high resolution MRI scans to establish a baseline for individual variation
Outcome measures
| Measure |
Ex-vivo
n=9 MRI scans
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=2 MRI scans
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum
Suspicious nodes on MRI after tracer injection
|
3 MRI scans
|
1 MRI scans
|
|
High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum
tracer uptake by tumour
|
6 MRI scans
|
1 MRI scans
|
|
High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum
extraneous mucosal tracer uptake
|
2 MRI scans
|
1 MRI scans
|
|
High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum
tracer uptake by mesorectal nodes
|
7 MRI scans
|
2 MRI scans
|
SECONDARY outcome
Timeframe: at time of surgeryPopulation: This measure only applies to the In-vivo group. Ex-vivo group did not undergo TEM surgery.
Sentimag probe is used to localise the sentinel node during TEM (transanal endoscopic microsurgery) and then remove it if possible
Outcome measures
| Measure |
Ex-vivo
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=1 TEM operations
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed
|
—
|
0 TEM operations
|
Adverse Events
Ex-vivo
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
In-vivo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ex-vivo
n=13 participants at risk
Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
In-vivo
n=2 participants at risk
Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.
Sienna+ injection: Endoscopic injection of magnetic tracer
MRI scan: MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)
|
|---|---|---|
|
Gastrointestinal disorders
Post-operative ileus
|
15.4%
2/13 • Number of events 2 • Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.
|
0.00%
0/2 • Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.
|
|
Gastrointestinal disorders
Anastomotic leak
|
15.4%
2/13 • Number of events 2 • Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.
|
0.00%
0/2 • Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.
|
Other adverse events
Adverse event data not reported
Additional Information
Miss Helen Jones
Oxford University Hospitals NHS Foundation Trust
Phone: 01865 235657
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place