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

NCT05892289 | Recruiting DMC

• 1 other identifier: SYSKY-2022-275-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Robotic Surgical Procedures; minimally invasive surgical procedures; stomach neoplasm; Gastrectomy; Reflux Esophagitis

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively

  During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification.

  12 months postoperatively

Secondary Outcomes (24)

• Quality of Life after Surgery

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively

• Gastrointestinal Symptoms after Surgery

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively

• Changes in total protein at Follow-up

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

• Changes in serum albumin at Follow-up

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

• Changes in prealbumin at Follow-up

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

Study Arms (1)

Robotic assisted proximal gastrectomy with double-flap technique

EXPERIMENTAL

Procedure: Robotic assisted proximal gastrectomy with double-flap technique

Interventions

Robotic assisted proximal gastrectomy with double-flap technique 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.

Robotic assisted proximal gastrectomy with double-flap technique

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years ≤ age ≤ 80 years
• The primary gastric lesions were located in the proximal third of the stomach
• histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
• 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)
• 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).).
• The preoperative American Society of Anesthesiologists (ASA) physical status was I-III;
• The patient's cardiopulmonary function can tolerate robotic assisted surgery;
• The subjects have signed the informed consent form.

You may not qualify if:

• history of upper abdominal surgery and not suitable for robotic assisted surgery
• the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
• with other malignant diseases or have suffered from other malignant diseases within 5 years
• Excessive tension for esophagogastric anastomosis and require changing the reconstruction procedure
• women are pregnant or in lactation period
• Suffering from serious mental illness
• history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• First Affiliated Hospital of Guangxi Medical University: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• First Hospital of China Medical University: collaborator
• Gansu Provincial Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shandong Provincial Hospital: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Sichuan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• LanZhou University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Zunyi Medical College: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Qinghai Province Cancer Hospital: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40789587 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophagitis; Esophageal Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Central Study Contacts

Yang bin, associate professor

CONTACT

13798163278; yyzsu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 7, 2023
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)