Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer

NCT ID: NCT05892289

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2026-12-10

Brief Summary

Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. The patients have poor nutritional status and quality of life after total gastrectomy. Compare to total gastrectomy, the nutritional status can improve after proximal gastrectomy . But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is high, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional condition than total gastrectomy.

Double-flap technique is a new surgical reconstruction procedure between esophagus and remnant stomach. It can reduce the occurrence of reflux oesophagitis through reconstruction a simulative cardia. At present, the technique has been carried out in some hospitals in China but still lack large-scale prospective studies and evidence of evidence-based medicine. At present, some retrospective studies have shown that robotic assisted proximal gastrectomy with double-flap technique is safe and effective, and the learning curve is shorter than laparoscopic surgery. The applicant have finished two robotic assisted proximal gastrectomy with double-flap technique cases. Two patients recovered well after surgery, with no occurrence of anastomotic leakage or stenosis and the postoperative quality of life was good. Now we plan to conduct a multi-center, single arm study on proximal early gastric cancer patients(T1N0-1M0 and T2N0M0) to evaluate the feasibility of robotic assisted proximal gastrectomy with double-flap technique , and to evaluate the surgical and oncological safety of this surgical method. Aim to provide initial evidence of evidence-based medicine for its clinical application..

Conditions

Stomach Neoplasms

Study Design

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

Study Groups

Robotic assisted proximal gastrectomy with double-flap technique

Group Type: EXPERIMENTAL

Robotic assisted proximal gastrectomy with double-flap technique

Intervention Type: PROCEDURE

Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.

Interventions

Robotic assisted proximal gastrectomy with double-flap technique

Patients in this group receive robotic assisted proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9，11p and 11d).The double-flap technique is used for the digestive tract reconstruction.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 20 years ≤ age ≤ 80 years

2. The primary gastric lesions were located in the proximal third of the stomach

3. histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)

4. clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer System(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)

5. scheduled for robotic assisted proximal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).

6. The preoperative American Society of Anesthesiologists (ASA) physical status was I-III;

7. The patient's cardiopulmonary function can tolerate robotic assisted surgery;

8. The subjects have signed the informed consent form.

Exclusion Criteria

1. history of upper abdominal surgery and not suitable for robotic assisted surgery

2. the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)

3. with other malignant diseases or have suffered from other malignant diseases within 5 years

4. Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure

5. women are pregnant or in lactation period

6. Suffering from serious mental illness

7. history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

LanZhou University

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Zunyi Medical College

OTHER

Sponsor Role: collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Qinghai Province Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang bin, associate professor

Role: CONTACT

yyzsu@163.com

13798163278

Facility Contacts

Yang bin

Role: primary

yyzsu@163.com

13798163278

References

Zhong G, Xie Y, Chen G, Zhu Y, Yang B, Tan J, Han F, Zhou S. Assessing the feasibility and safety of robotic-assisted proximal gastrectomy with double-flap technique for proximal early gastric cancer: study protocol for a phase II, multicentre, single-arm clinical trial. BMJ Open. 2025 Aug 10;15(8):e094661. doi: 10.1136/bmjopen-2024-094661.

Reference Type: DERIVED

PMID: 40789587 (View on PubMed)

Other Identifiers

SYSKY-2022-275-02

Identifier Type: -

Identifier Source: org_study_id