Feasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer
- Conditions
- Stomach Neoplasms
- Interventions
- Procedure: Robotic assisted proximal gastrectomy with double-flap technique
- Registration Number
- NCT05892289
- 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..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Robotic assisted proximal gastrectomy with double-flap technique Robotic assisted proximal gastrectomy with double-flap technique -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of participants die after surgery From surgery to discharge, up to 30 days mortality rate
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.
Changes in total protein at Follow-up Follow-up evaluations are performed 3, 6 and 12 months postoperatively. blood total protein(g/L) levels
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.
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.
Proportion of participants need to rehospitalized after surgery From surgery to discharge, up to 30 days rehospitalization rate
Pathological Characteristics 1 week postoperatively number of dissected lymph nodes for each patient in the surgery
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.
Changes in hemoglobin at Follow-up Follow-up evaluations are performed 3, 6 and 12 months postoperatively. blood hemoglobin(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
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.
Short-term Clinical Outcome After Surgery From surgery to discharge, up to 30 days length of postoperative hospitalisation(days)
Surgical Characteristics 24 hours postoperatively blood loss during surgery(ml)
Changes in Vitamin B12 at Follow-up Follow-up evaluations are performed 3, 6 and 12 months postoperatively. blood Vitamin B12(μg/ml) levels
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.
body mass index postoperatively Follow-up evaluations are performed 3, 6 and 12 months postoperatively. body mass index(kg/m\^2)
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China