Gastric Cancer Sentinel Lymph Node Mapping

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

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.

It had 1 arm (groups): Sentinel Node Sampling Arm (experimental).

The registry classes the interventions as drug and procedure.

More on the Plan

Gastric cancer incidence in North America is 7.4/100,000 population, with 24,590 new cases diagnosed annually in the United States1.

However, the mainstay of treatment even for early gastric cancers (EGC) remains anatomical resection with regional lymphadenectomy.

Recently, organ-sparing techniques have emerged which allow select early gastric cancers to be treated without anatomical resection.

These techniques, including endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), allow for curative resection of highly-selected lesions with complete organ preservation.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: not able to withstand anatomical gastric resection with d2 lymphadenectomy, patient refusal, n+ve disease on pre-op work up, disease progression before surgery.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-07-01 with completion listed for 2022-06-30.

It ran at 1 site in Canada.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: 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). Sensitivity of Sentinel Lymph Node Sampling Method (time frame: 3-4 weeks after study completion). Specificity of Sentinel Lymph Node Sampling Method (time frame: 3-4 weeks after study completion).

It also tracked 8 secondary outcomes, for example Adverse events due to SLN sampling technique, Length of stay, R0 Resection rate, 3 year Disease free survival rate, conversion to open and Patient mortality.

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.