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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Adenocarcinoma of Esophagogastric Junction
• Intervention / Treatment: Procedure: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Hankun Hao, doctor; Phone Number: +86 18121186328; Email: haohankun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Procedure: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique; Surgical Operation: Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach.; Lymph Node Dissection Range:D1+ to D2 lymph node dissection.; Anastomosis Method: esophagogastrostomy by fissure technique.; Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis.; Surgical Approach:Totally laparoscopic proximal gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess intraoperative Perioperative Safety by Duration of surgery.	Time spent on the whole operation（minutes）	intraoperative
Assess intraoperative Perioperative Safety by Duration of anastomosis.	Time spent on the anastomosis in minutes	intraoperative
Assess intraoperative Perioperative Safety by blood loss .	Intraoperative blood loss in milliliters	intraoperative
Postoperative recovery course	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.	30 days after the surgery
Postoperative TNM staging by Pathological findings .	AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor .	30 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative reflux esophagitis	Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination	3 months after surgery
The incidence of postoperative anastomotic stenosis	Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination	3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30	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.	3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale	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.	3 months after surgery

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: proximal gastrectomy; totally laparoscopic gastrectomy; fissure technique
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Esophageal Neoplasms; Adenocarcinoma
• Other Study ID Numbers: 2023-1058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No