Gastric Cancer Sentinel Lymph Node Mapping

NCT03049345 | Unknown

• 1 other identifier: 14-288-GEN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Sentinel Lymph Node; Early Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Number of patients in whom sentinel lymph node status accurately predicts true nodal status after anatomical gastrectomy and complete pathological examination

  The % of patients in whom SLN status matched nodal status overall will be calculated

  3-4 weeks after study completion

• Sensitivity of Sentinel Lymph Node Sampling Method

  \# of patients with +ve SLN / # of patients with +ve lymph nodes in total

  3-4 weeks after study completion

• Specificity of Sentinel Lymph Node Sampling Method

  \# of patients with -ve SLNs / # of patients with -ve lymph nodes in total

  3-4 weeks after study completion

Secondary Outcomes (8)

• Adverse events due to SLN sampling technique

  at time of surgery

• Length of stay

  90 days from study completion

• R0 Resection rate

  3-4 weeks after study completion

• 3 year Disease free survival rate

  3 years after study completion

• conversion to open

  at time of surgery

Study Arms (1)

Sentinel Node Sampling Arm

EXPERIMENTAL

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; Drug: Radioactive Tracers; Drug: Methylene Blue 20 MG/ML

Interventions

Sentinel Lymph Node Sampling PROCEDURE

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.

Sentinel Node Sampling Arm

Radioactive Tracers DRUG

see above

Sentinel Node Sampling Arm

Methylene Blue 20 MG/ML DRUG

see above

Sentinel Node Sampling Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

RECRUITING

Related Publications (3)

• Kitagawa Y, Takeuchi H, Takagi Y, Natsugoe S, Terashima M, Murakami N, Fujimura T, Tsujimoto H, Hayashi H, Yoshimizu N, Takagane A, Mohri Y, Nabeshima K, Uenosono Y, Kinami S, Sakamoto J, Morita S, Aikou T, Miwa K, Kitajima M. Sentinel node mapping for gastric cancer: a prospective multicenter trial in Japan. J Clin Oncol. 2013 Oct 10;31(29):3704-10. doi: 10.1200/JCO.2013.50.3789. Epub 2013 Sep 9.

  PMID: 24019550 BACKGROUND

• Gotoda T, Yanagisawa A, Sasako M, Ono H, Nakanishi Y, Shimoda T, Kato Y. Incidence of lymph node metastasis from early gastric cancer: estimation with a large number of cases at two large centers. Gastric Cancer. 2000 Dec;3(4):219-225. doi: 10.1007/pl00011720.

  PMID: 11984739 BACKGROUND

• Mueller CL, Lisbona R, Sorial R, Siblini A, Ferri LE. Sentinel Lymph Node Sampling for Early Gastric Cancer-Preliminary Results of A North American Prospective Study. J Gastrointest Surg. 2019 Jun;23(6):1113-1121. doi: 10.1007/s11605-018-04098-5. Epub 2019 Mar 11.

  PMID: 30859424 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Radioactive Tracers; Methylene Blue

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Radioisotopes; Isotopes; Inorganic Chemicals; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: human subjects

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 10, 2017
• Study Start: July 1, 2016
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)