Fluorescent dye guides Stomach-Sparing surgery for early cancer
NCT ID NCT07708012
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests a surgical technique for early stomach cancer that combines a camera in the abdomen (laparoscopy) with a flexible tube down the throat (endoscopy). Doctors inject a fluorescent dye near the tumor to highlight the first lymph nodes that might contain cancer. If those nodes are cancer-free, they remove only the tumor and a small part of the stomach, preserving more normal function. The goal is to see if this approach is safe and effective while reducing side effects compared to standard surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combined laparoscopic and endoscopic surgical procedure using fluorescent dye (indocyanine green) to identify and remove sentinel lymph nodes and the primary tumor
- What this could lead to
- If successful, this approach could offer a less invasive, stomach-preserving surgical option for early stomach cancer patients, reducing long-term side effects.
- What could go wrong
- This is a small, single-center study with only 30 participants, so results may not apply broadly. The procedure's safety and effectiveness need confirmation in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2026
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80, any gender; 2. Gastric adenocarcinoma confirmed by gastroscopic biopsy, with a single lesion; 3. Clinical staging cT1N0M0 based on enhanced CT, endoscopic ultrasound and other imaging evaluations (tumour limited to the mucosa or submucosa with no evidence of lymph node or distant metastasis); 4. Absolute indications for endoscopic submucosal dissection (ESD), with lesions no larger than 5cm, or cases where endoscopic removal is difficult. Absolute indications for ESD (differentiated carcinoma, mucosal T1a stage, without ulcer ≤2 cm or with ulcer ≤3 cm; undifferentiated carcinoma without ulcer ≤2 cm. Difficult cases for endoscopic removal: negative "lifting sign", laterally spreading tumours and scar ulcers etc.); 5. Meets eCURA score criteria for non-curative ESD requiring additional surgery; 6. ECOG performance status 0-1; 7. Patient fully informed and consents, signing the consent form. Note: For inclusion, meeting either criterion ④ or ⑤ is sufficient. Exclusion Criteria: 1. Pregnant or breastfeeding women; 2. Those with a history of major upper abdominal surgery where severe abdominal adhesions are expected; 3. Patients with recurrent gastric cancer, multiple primary tumours, or those who have undergone preoperative chemoradiotherapy; 4. Those meeting ESD indications and having completed curative endoscopic resection according to eCURA standards \[12,13\]; 5. Patients with other unresectable malignant tumours; 6. Those with severe heart, lung, liver, or kidney dysfunction who cannot tolerate general anaesthesia and surgery; 7. Those allergic to indocyanine green (ICG) or nano carbon tracers; 8. Those with mental illness who cannot cooperate with the study and follow-up.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Early gastric cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Qingdao University Affiliated Hospital West Coast Campus
Qingdao, Shandong, 266000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can western patients skip surgery for early stomach cancer?
- Which treatment for early stomach cancer offers the best Long-Term survival?
- Stomach bug clues: can infection patterns forecast early cancer behavior?
- New Dual-Scope surgery shows promise for early stomach cancer
- Keyhole surgery offers relief for hidden hiatal hernia sufferers
- AI could help endoscopists catch stomach cancer earlier