BridgeMD
New treatment option for Gastric Cancer
Official title A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
ClinicalTrials.gov ID: NCT06300879
What this study is testing
- What it's testing
- This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III). The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique.
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 between 18 and 75 years old;
- Pathologically confirmed as adenocarcinoma;
- Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
- If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
- For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around...
You likely can't join if
- Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
- Pregnant or lactating women;
- Patients with severe mental illness;
- Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
- Severe respiratory diseases, with FEV1 \< 50% of predicted value;
- History of other malignant tumors in the past 5 years;
See the full eligibility criteria
- Age between 18 and 75 years old;
- Pathologically confirmed as adenocarcinoma;
- Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
- If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
- For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
- Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
- No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
- No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
- Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
- Preoperative ASA (American Society of Anesthesiologists) score I-III.
- Good function of important organs.
- Signed informed consent.
- Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
- Pregnant or lactating women;
- Patients with severe mental illness;
- Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
- Severe respiratory diseases, with FEV1 \< 50% of predicted value;
- History of other malignant tumors in the past 5 years;
- Severe liver or kidney dysfunction;
- Unstable angina or myocardial infarction within the last 6 months;
- History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
- Systemic use of glucocorticoids within the last 1 month;
- Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
- Patient has participated in or is currently participating in other clinical trials (within the last 6 months).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 - 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?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.