Stomach Neoplasms
Conditions
Keywords
Robotic Surgical Procedures, minimally invasive surgical procedures, stomach neoplasm, Gastrectomy, Reflux Esophagitis
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..
Interventions
PROCEDURERobotic 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.
Sponsors
First Affiliated Hospital of Guangxi Medical University
First Affiliated Hospital of Kunming Medical University
First Hospital of China Medical University
Gansu Provincial Hospital
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Sichuan Cancer Hospital and Research Institute
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
LanZhou University
Third Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University Cancer Institute and Hospital
Zunyi Medical College
Liaoning Cancer Hospital & Institute
Qinghai Province Cancer Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively | 12 months postoperatively | During follow-up endoscopy 1 year after surgery, reflux esophagitis were graded according to the Los Angeles (LA) classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptoms after Surgery | Follow-up evaluations are performed 3, 6 and 12 months postoperatively | gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome. |
| Changes in total protein at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood total protein(g/L) levels |
| Changes in serum albumin at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood serum albumin(g/L) levels |
| Changes in prealbumin at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood prealbumin(g/L) levels |
| Changes in hemoglobin at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood hemoglobin(g/L) levels |
| Changes in Vitamin B12 at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood Vitamin B12(μg/ml) levels |
| Late Postoperative Morbidity | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard. |
| Early Postoperative Morbidity | From surgery to discharge, up to 30 days | 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. |
| Quality of Life after Surgery | Follow-up evaluations are performed 3, 6 and 12 months postoperatively | 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. |
| Surgical Characteristics | 24 hours postoperatively | operative time(minutes) |
| Quality of Life postoperatively | Follow-up evaluations are performed 3, 6 and 12 months 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. |
| Pathological Characteristics | 1 week postoperatively | R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor. |
| body mass index postoperatively | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | body mass index(kg/m\^2) |
| pain assessment postoperatively | Day 1 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. |
| Proportion of participants die after surgery | From surgery to discharge, up to 30 days | mortality rate |
| Proportion of participants need to rehospitalized after surgery | From surgery to discharge, up to 30 days | rehospitalization rate |
| Short-term Clinical Outcome After Surgery | From surgery to discharge, up to 30 days | time to pass gas(hours) |
Countries
China
Contacts
Primary ContactYang bin, associate professor
Outcome results
None listed