A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

Not Applicable

Recruiting

• Conditions: Gastric Cancer; Adenocarcinoma of Esophagogastric Junction
• Interventions: Procedure: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

• Registration Number: NCT06300879
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age between 18 and 75 years old;
2. Pathologically confirmed as adenocarcinoma;
3. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
4. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
5. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
6. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
7. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
8. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
9. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
10. Preoperative ASA (American Society of Anesthesiologists) score I-III.
11. Good function of important organs.
12. Signed informed consent.

Exclusion Criteria

1. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
2. Pregnant or lactating women;
3. Patients with severe mental illness;
4. Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
5. Severe respiratory diseases, with FEV1 < 50% of predicted value;
6. History of other malignant tumors in the past 5 years;
7. Severe liver or kidney dysfunction;
8. Unstable angina or myocardial infarction within the last 6 months;
9. History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
10. Systemic use of glucocorticoids within the last 1 month;
11. Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
12. Patient has participated in or is currently participating in other clinical trials (within the last 6 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique	Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Primary Outcome Measures

Name	Time	Method
Assess intraoperative Perioperative Safety by Duration of surgery.	intraoperative	Time spent on the whole operation（minutes）
Assess intraoperative Perioperative Safety by blood loss .	intraoperative	Intraoperative blood loss in milliliters
Postoperative TNM staging by Pathological findings .	30 days after the surgery	AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor .
Postoperative recovery course	30 days after the surgery	Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Assess intraoperative Perioperative Safety by Duration of anastomosis.	intraoperative	Time spent on the anastomosis in minutes

Secondary Outcome Measures

Name	Time	Method
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30	3 months after surgery	QLQ-C30 is a comprehensive assessment of the overall quality of life dimensions before and after surgery for patients. Higher scores represent poorer quality of life for patients after surgery.
The incidence of postoperative reflux esophagitis	3 months after surgery	Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
The incidence of postoperative anastomotic stenosis	3 months after surgery	Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale	3 months after surgery	QLQ-STO22 is a specific assessment for postoperative situations related to anastomosis, such as swallowing and eating.Higher scores represent poorer quality of life for patients after surgery.

Trial Locations

Locations (1)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China