Clinical trial for Early-stage Upper Gastrointestinal Cancer
Official title Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer
ClinicalTrials.gov ID: NCT07708012
What this study is testing
- What it's testing
- Gastric cancer is a common malignant tumour worldwide, and in China, the incidence and mortality rates of gastric cancer remain high.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Gastroscopy biopsy confirmed a solitary gastric adenocarcinoma;
- White light endoscopy, magnifying endoscopy-image-enhanced endoscopy，(ME-IEE）, endoscopic ultrasound and enhanced CT comprehensively assessed as...
- Assessed by MDT as unsuitable for simple ESD: including cases beyond the current guideline/consensus recommended ESD curative resection indications...
- Lesion maximum diameter in principle ≤5 cm; for lesions close to 5 cm, near the cardia/pylorus or expected to cause stenosis or significant gastric...
- ECOG performance status score 0-1, able to tolerate general anaesthesia and laparoscopic surgery;
You likely can't join if
- Preoperative imaging, endoscopy or MDT suggests cT2 or above, definite lymph node metastasis or distant metastasis;
- Pregnant or breastfeeding women;
- Previous major upper abdominal surgery leading to expected severe adhesions, significantly affecting SLB localisation or surgical implementation;
- Recurrent gastric cancer, multiple primary gastric cancers, or those who received preoperative radiotherapy and chemotherapy;
- Cases that have undergone ESD removal and achieved curative resection according to eCura standards;
- History of severe ICG allergy or deemed unsuitable by the researcher to use ICG;
See the full eligibility criteria
- Gastroscopy biopsy confirmed a solitary gastric adenocarcinoma;
- White light endoscopy, magnifying endoscopy-image-enhanced endoscopy，(ME-IEE）, endoscopic ultrasound and enhanced CT comprehensively assessed as cT1N0M0, with no distant metastasis;
- Assessed by MDT as unsuitable for simple ESD: including cases beyond the current guideline/consensus recommended ESD curative resection indications, or although at the endoscopic treatment border, significant fibrosis...
- Lesion maximum diameter in principle ≤5 cm; for lesions close to 5 cm, near the cardia/pylorus or expected to cause stenosis or significant gastric deformation after local resection, they are listed as key review cases...
- ECOG performance status score 0-1, able to tolerate general anaesthesia and laparoscopic surgery;
- Patient fully understands the potential benefits and uncertainties of SNNS/LECS, the possible false-negative risk of ICG single tracing and intraoperative pathology, as well as the possibility of conversion/additional...
- Preoperative imaging, endoscopy or MDT suggests cT2 or above, definite lymph node metastasis or distant metastasis;
- Pregnant or breastfeeding women;
- Previous major upper abdominal surgery leading to expected severe adhesions, significantly affecting SLB localisation or surgical implementation;
- Recurrent gastric cancer, multiple primary gastric cancers, or those who received preoperative radiotherapy and chemotherapy;
- Cases that have undergone ESD removal and achieved curative resection according to eCura standards;
- History of severe ICG allergy or deemed unsuitable by the researcher to use ICG;
- Patients with other untreated malignant tumours, severe cardiopulmonary dysfunction, or other conditions unable to tolerate general anaesthesia and pneumoperitoneum;
- Those unable to understand the study process or complete standard follow-up.
The study team makes the final eligibility decision.
Where it is enrolling
- Qingdao, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Qingdao, Shandong, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.