Trial studying safety and effects for Gastric Cancer
Official title Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT07142122
What this study is testing
- What it's testing
- The study wants to see if preserving the celiac vagus nerve during surgery affects safety, stomach emptying, reflux, quality of life, and cancer outcomes compared to not preserving it.
- Who it's for
- Adults with early-stage cancer in the upper part of the stomach who are candidates for total laparoscopic proximal gastrectomy.
- What's involved
- Participants will have the planned laparoscopic surgery with either both hepatic and celiac nerve branches kept or only the hepatic branch kept, followed by regular check‑ups, imaging, endoscopy, and questionnaires about symptoms and quality of life.
- Time commitment
- The trial involves the surgery plus follow‑up visits for at least 6 months, with additional assessments up to 3 years after the operation.
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 75
You may be able to join if
- Age 18-75 years.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including...
- Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
- Clinical stage cT1bN0M0 without lymph node metastasis.
- BMI \<30 kg/m².
You likely can't join if
- Pregnancy or breastfeeding.
- Other malignancies within 5 years.
- Active infection requiring systemic therapy or fever ≥38°C preoperatively.
- Severe psychiatric illness.
- Severe respiratory disease.
- Severe hepatic or renal dysfunction.
See the full eligibility criteria
- Age 18-75 years.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
- Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
- Clinical stage cT1bN0M0 without lymph node metastasis.
- BMI \<30 kg/m².
- No history of upper abdominal surgery (except laparoscopic cholecystectomy).
- No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- ECOG performance status 0-1.
- ASA class I-III.
- Adequate organ function.
- Signed informed consent.
- Pregnancy or breastfeeding.
- Other malignancies within 5 years.
- Active infection requiring systemic therapy or fever ≥38°C preoperatively.
- Severe psychiatric illness.
- Severe respiratory disease.
- Severe hepatic or renal dysfunction.
- Unstable angina or myocardial infarction within 6 months.
- Stroke or intracranial hemorrhage within 6 months.
- Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
- Complications of gastric cancer (bleeding, perforation, obstruction).
- Participation in another clinical study within 6 months. Exclusion During Study (Removal Criteria): R0 resection not achieved, change of procedure to total gastrectomy or PPG, combined surgery for other diseases, severe...
The study team makes the final eligibility decision.
Where it is enrolling
- Fuzhou, Fujian, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fuzhou, Fujian, 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.