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

Official title

Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer: a Phase II, Multi-center, Single-arm Clinical Study

Overview

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..

Interventions

• Procedure 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.

Primary outcome measures

• The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively [Time frame: 12 months postoperatively]

Secondary outcome measures (12)

• Quality of Life after Surgery [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
• Gastrointestinal Symptoms after Surgery [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
• Changes in total protein at Follow-up [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in serum albumin at Follow-up [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in prealbumin at Follow-up [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in hemoglobin at Follow-up [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in Vitamin B12 at Follow-up [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Late Postoperative Morbidity [Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Early Postoperative Morbidity [Time frame: From surgery to discharge, up to 30 days]
• Short-term Clinical Outcome After Surgery [Time frame: From surgery to discharge, up to 30 days]
• Short-term Clinical Outcome After Surgery [Time frame: From surgery to discharge, up to 30 days]
• Short-term Clinical Outcome After Surgery [Time frame: From surgery to discharge, up to 30 days]

Eligibility criteria

Inclusion criteria

• 20 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou

Publications

• 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

Identifiers

NCT: NCT05892289 · SYSKY-2022-275-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗