Actively Recruiting
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
Led by Huashan Hospital · Updated on 2025-05-02
30
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Confirmed adenocarcinoma diagnosis
- Primary tumor located in the upper third of the stomach or gastroesophageal junction (Siewert II or III)
- For stomach adenocarcinoma, clinical stage cT1N0M0
- For gastroesophageal junction adenocarcinoma, clinical stage cT1-2N0M0 with no distant lymph node metastasis
- Bilateral resection margins greater than 2 cm and preservation of more than half of the residual stomach
- No history of upper abdominal surgery except laparoscopic cholecystectomy
- No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Preoperative ECOG score of 0 or 1
- Preoperative ASA score between I and III
- Good function of important organs
- Signed informed consent
You will not qualify if you...
- Clinical assessment showing cT4b stage, bulky lymph node enlargement, or distant lymph node metastasis
- Pregnancy or breastfeeding
- Severe mental illness
- Preoperative fever of 38°C or higher or infectious diseases needing systemic treatment
- Severe respiratory disease with FEV1 less than 50% of predicted
- History of other cancers within the past 5 years
- Severe liver or kidney dysfunction
- Unstable angina or heart attack within the last 6 months
- Stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts)
- Systemic glucocorticoid use within the past month
- Need for emergency surgery due to gastric cancer complications like bleeding, perforation, or obstruction
- Participation in other clinical trials within the last 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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