A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

NCT ID: NCT06300879

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-06-30

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.

Conditions

Gastric Cancer; Adenocarcinoma of Esophagogastric Junction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Group Type: EXPERIMENTAL

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Intervention Type: PROCEDURE

Surgical Operation:

1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach.

2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection.

3. Anastomosis Method: esophagogastrostomy by fissure technique.

4. 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.

5. Surgical Approach:Totally laparoscopic proximal gastrectomy.

Interventions

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Surgical Operation:

1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach.

2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection.

3. Anastomosis Method: esophagogastrostomy by fissure technique.

4. 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.

5. Surgical Approach:Totally laparoscopic proximal gastrectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Hankun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hankun Hao, doctor

Role: primary

haohankun@163.com

+86 18121186328

Other Identifiers

2023-1058

Identifier Type: -

Identifier Source: org_study_id