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Trial record 1 of 9 for:    Recruiting Studies | Interventional Studies | Gastric Cancer | quebec | Canada
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Gastric Cancer Sentinel Lymph Node Mapping

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ClinicalTrials.gov Identifier: NCT03049345
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Carmen Mueller, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

Gastric cancer has an incidence in North America of over 24,000 new cases annually, of which approximately 15% are diagnosed at an early stage. Standard of care for early gastric cancer (EGC) treatment has historically included anatomical resection with regional lymphadenectomy. However, with the recent emergence of organ-sparing techniques, select patients with a very low risk of lymph node metastases are able to avoid anatomical resection and its inherent short and long term consequences. Despite this advance, EGC patients with high risk features continue to require anatomical resection to achieve adequate lymph node staging, despite the fact that 75-95% of these patients ultimately are found to have node negative disease. Due to the inadequacy of standard imaging modalities to reliably detect nodal metastases in EGC patients, sentinel lymph node sampling for gastric cancer was developed using principals similar to those used broadly for breast and melanoma patients. Early reports from Asia suggest this technique has very high success rates, accuracy and sensitivity, however it has never been verified in a North American context. This study aims to test SLN sampling for North American gastric cancer patients at a high volume regional treatment centre, with an aim to expand the application of organ sparing resection to EGC patients.

This project aims to determine the sensitivity and accuracy of sentinel lymph node sampling for early gastric cancer patients at a high volume, North American, tertiary care centre.


Condition or disease Intervention/treatment Phase
Gastric Cancer Sentinel Lymph Node Early Gastric Cancer Procedure: Sentinel Lymph Node Sampling Drug: Radioactive Tracers Drug: Methylene Blue 20 MG/ML Not Applicable

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Study Type : Interventional
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: human subjects
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Diagnostic
Official Title: Gastric Cancer Sentinel Lymph Node Sampling: Refining Patient Selection for Organ Sparing Resection of Early Gastric Cancer in a North American Context
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Sentinel Node Sampling Arm
The day before surgery, 2mL of endoscopically-placed technetium 99m sulfur colloid solution will be injected submucosally at 4 points around the tumour. At the time of surgery, 2cc of 1% isosulfan blue dye will be similarly injected. Laparoscopically, the gastrocolic ligament will be opened to expose all gastric lymph node drainage basins. Using visual inspection and a laparoscopic gamma probe, blue nodes and those emitting 10x greater than background activity will be considered sentinel nodes and extracted. Patients will then under regular gastric cancer resection with D2 lymphadenectomy as per routine in our institution.
Procedure: Sentinel Lymph Node Sampling
The day before surgery, 2mL of endoscopically-placed technetium 99m sulfur colloid solution will be injected submucosally at 4 points around the tumour. At the time of surgery, 2cc of 1% isosulfan blue dye will be similarly injected. Laparoscopically, the gastrocolic ligament will be opened to expose all gastric lymph node drainage basins. Using visual inspection and a laparoscopic gamma probe, blue nodes and those emitting 10x greater than background activity will be considered sentinel nodes and extracted. Sentinel lymph nodes and resected specimens will be analyzed by permanent section.

Drug: Radioactive Tracers
see above

Drug: Methylene Blue 20 MG/ML
see above




Primary Outcome Measures :
  1. Number of patients in whom sentinel lymph node status accurately predicts true nodal status after anatomical gastrectomy and complete pathological examination [ Time Frame: 3-4 weeks after study completion ]
    The % of patients in whom SLN status matched nodal status overall will be calculated

  2. Sensitivity of Sentinel Lymph Node Sampling Method [ Time Frame: 3-4 weeks after study completion ]
    # of patients with +ve SLN / # of patients with +ve lymph nodes in total

  3. Specificity of Sentinel Lymph Node Sampling Method [ Time Frame: 3-4 weeks after study completion ]
    # of patients with -ve SLNs / # of patients with -ve lymph nodes in total


Secondary Outcome Measures :
  1. Adverse events due to SLN sampling technique [ Time Frame: at time of surgery ]
    Complications of SLN intervention (allergic reaction, intra-operative bleeding, conversion to open approach)

  2. Length of stay [ Time Frame: 90 days from study completion ]
    # of days patient stays in hospital after procedure

  3. R0 Resection rate [ Time Frame: 3-4 weeks after study completion ]
    # of patients who have complete measurable disease excision at time of surgery

  4. 3 year Disease free survival rate [ Time Frame: 3 years after study completion ]
    # of patients who are free of gastric cancer at 3 years out of all study patients

  5. conversion to open [ Time Frame: at time of surgery ]
    Number of patients who required a conversion to open technique after starting laparoscopically

  6. Patient mortality [ Time Frame: 90 days after surgery ]
    # of patients who die within 30 days of surgery or who die while in hospital

  7. 3 year overall survival rate [ Time Frame: 3 years after study completion ]
    number of patients who are still alive at 3 years out of all study patients

  8. Adverse surgical events [ Time Frame: 30 days after study completion ]
    # of patients who suffered any of the following surgical complications: urinary tract infection, pneumonia, ileus, anastomotic leak, reoperation within 30 days of surgery, readmission within 30 days of discharge, myocardial infarction, venous thromboembolism, bleeding requiring blood transfusion



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who are deemed healthy enough to withstand laparoscopic or open anatomic gastrectomy with extended regional (D2) lymphadenectomy will be eligible. Patients much have biopsy-proven, single lesion, <4cm gastric adenocarcinoma, of stage cT1/T2/T3 N0 M0.

Exclusion Criteria:

  • Not able to withstand anatomical gastric resection with D2 lymphadenectomy, patient refusal, N+ve disease on pre-op work up, disease progression before surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049345


Locations
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Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Carmen L Mueller, MD MEd    5146776465    carmen.mueller@mcgill.ca   
Principal Investigator: Carmen L Mueller, MD MEd         
Sub-Investigator: Lorenzo E Ferri, MD PhD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carmen Mueller, Assistant Professor of Surgery, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03049345    
Other Study ID Numbers: 14-288-GEN
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action