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RECRUITINGNA

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

NCT06300879•Huashan Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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;
+2 more criteria

Locations (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 1, 2024

Primary Completion Date

December 31, 2025

Completion Date

June 30, 2026

Last Updated

May 2, 2025

Enrollment

ESTIMATED participants

Conditions

Gastric CancerAdenocarcinoma of Esophagogastric Junction

Interventions

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

Inclusion Criteria

Exclusion Criteria

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