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Sentinel Lymph Node Sampling for Sentinel Lymph Node

N/A

Waitlist Available

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days from study completion

Awards & highlights

Study Summary

This trial will help to establish whether sentinel lymph node sampling is a reliable method for detecting gastric cancer in North American patients, which could potentially expand the use of organ-sparing surgery for early gastric cancer patients.

Eligible Conditions

Sentinel Lymph Node
Gastric Cancer
Stomach Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastrectomy

Sensitivity of Sentinel Lymph Node Sampling Method

Specificity of Sentinel Lymph Node Sampling Method

Secondary outcome measures

3 year Disease free survival rate

3 year overall survival rate

Adverse events due to SLN sampling technique

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sentinel Node Sampling ArmExperimental Treatment3 Interventions

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.

0 / 1Eligibility criteria met