An interventional study of Robotic assisted proximal gastrectomy with double-flap technique in Stomach Neoplasms, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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..
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 42 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
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Exclusion Criteria:
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.
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.
Time frame: 12 months postoperatively
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.
Time frame: 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.
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Changes in total protein at Follow-up
blood total protein(g/L) levels
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in serum albumin at Follow-up
blood serum albumin(g/L) levels
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in prealbumin at Follow-up
blood prealbumin(g/L) levels
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in hemoglobin at Follow-up
blood hemoglobin(g/L) levels
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in Vitamin B12 at Follow-up
blood Vitamin B12(μg/ml) levels
Time frame: 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.
Time frame: 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.
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
time to pass gas(hours)
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
time to oral intake(hours)
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
time to indwell gastric tube(hours)
Time frame: From surgery to discharge, up to 30 days
Short-term Clinical Outcome After Surgery
length of postoperative hospitalisation(days)
Time frame: From surgery to discharge, up to 30 days
Surgical Characteristics
operative time(minutes)
Time frame: 24 hours postoperatively
Surgical Characteristics
time for reconstruction the digestive tract(minutes) during surgery
Time frame: 24 hours postoperatively
Surgical Characteristics
blood loss during surgery(ml)
Time frame: 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.
Time frame: 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.
Time frame: 1 week postoperatively
Pathological Characteristics
lymph nodes dissection extent for each patient in the surgery
Time frame: 1 week postoperatively
Pathological Characteristics
number of dissected lymph nodes for each patient in the surgery
Time frame: 1 week postoperatively
body mass index postoperatively
body mass index(kg/m\^2)
Time frame: 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.
Time frame: Day 1 postoperatively
Proportion of participants die after surgery
mortality rate
Time frame: From surgery to discharge, up to 30 days
Proportion of participants need to rehospitalized after surgery
rehospitalization rate
Time frame: From surgery to discharge, up to 30 days
Plan to share: Yes — The data sets generated and/or analysed during the current study are not publicly available due to governmental policy regarding individual information. However, they are available from the Sun Yat-Sen Memorial Hospital data center upon reasonable request, subject to approval by the Sun Yat-Sen Memorial Hospital Ethics Committee and the Data and Safety Monitoring Committee. This will be after the publication of the main findings, in line with standard data-sharing practices for clinical trial data sets. The Sun Yat-Sen Memorial Hospital data center will ensure the confidentiality of all participants' data and will not disclose information by which participants may be identified to any third party other than those directly involved in the treatment of the participant and organisations for which the participant has provided explicit consent for data transfer.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University