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

Study Overview
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Brief Summary
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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..

Official Title
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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

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: Robotic assisted proximal gastrectomy with double-flap technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic assisted proximal gastrectomy with double-flap technique<br> | Procedure: Robotic assisted proximal gastrectomy with double-flap technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life after Surgery | Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) 30-item core QoL (QLQ-C30 ver.3.0). Higher scores mean a worse outcome. | Follow-up evaluations are performed 3, 6 and 12 months postoperatively | 
| Gastrointestinal Symptoms after Surgery | gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome. | Follow-up evaluations are performed 3, 6 and 12 months postoperatively | 
| Changes in total protein at Follow-up | blood total protein(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| Changes in serum albumin at Follow-up | blood serum albumin(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| Changes in prealbumin at Follow-up | blood prealbumin(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| Changes in hemoglobin at Follow-up | blood hemoglobin(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| Changes in Vitamin B12 at Follow-up | blood Vitamin B12(μg/ml) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| Late Postoperative Morbidity | adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard. | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| Early Postoperative Morbidity | operation wound with seroma, hematoma, infection, dehiscence, or evisceration, anastomotic leakage, anastomotic bleeding, abdominal bleeding, abdominal abscess, intestinal obstruction morbidity, gastrointestinal bleeding, gastroparesis, postoperative pancreatitis, pancreatic fistula, chylous leakage, lung morbidity, cerebrovascular morbidity, cardiovascular morbidity, deep vein thrombosis, cholecystitis, liver dysfunction, kidney dysfunction. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard. | From surgery to discharge, up to 30 days | 
| Short-term Clinical Outcome After Surgery | time to pass gas(hours) | From surgery to discharge, up to 30 days | 
| Short-term Clinical Outcome After Surgery | time to oral intake(hours) | From surgery to discharge, up to 30 days | 
| Short-term Clinical Outcome After Surgery | time to indwell gastric tube(hours) | From surgery to discharge, up to 30 days | 
| Short-term Clinical Outcome After Surgery | length of postoperative hospitalisation(days) | From surgery to discharge, up to 30 days | 
| Surgical Characteristics | operative time(minutes) | 24 hours postoperatively | 
| Surgical Characteristics | time for reconstruction the digestive tract(minutes) during surgery | 24 hours postoperatively | 
| Surgical Characteristics | blood loss during surgery(ml) | 24 hours postoperatively | 
| Quality of Life postoperatively | Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) gastric cancer module (QLQ-STO22) questionnaire. Higher scores mean a worse outcome. | Follow-up evaluations are performed 3, 6 and 12 months postoperatively | 
| Pathological Characteristics | R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor. | 1 week postoperatively | 
| Pathological Characteristics | lymph nodes dissection extent for each patient in the surgery | 1 week postoperatively | 
| Pathological Characteristics | number of dissected lymph nodes for each patient in the surgery | 1 week postoperatively | 
| body mass index postoperatively | body mass index(kg/m^2) | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | 
| pain assessment postoperatively | We measured the pain score using visual analog scale(VAS) at 24 h after the surgery is completed. Higher scores mean a worse outcome. | Day 1 postoperatively | 
| Proportion of participants die after surgery | mortality rate | From surgery to discharge, up to 30 days | 
| Proportion of participants need to rehospitalized after surgery | rehospitalization rate | From surgery to discharge, up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Surgical Procedures, minimally invasive surgical procedures, stomach neoplasm, Gastrectomy, Reflux Esophagitis