NCT06300879Recruiting
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Feb 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Huashan Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06300879
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jan 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Unstable angina or myocardial infarction within the last 6 months;
- History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
- Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
Other
- Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
- Pregnant or lactating women;
- Severe liver or kidney dysfunction;
- Systemic use of glucocorticoids within the last 1 month;
- Patient has participated in or is currently participating in other clinical trials (within the last 6 months).
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.