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| Name | Class |
|---|---|
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| First Hospital of China Medical University | OTHER |
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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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic assisted proximal gastrectomy with double-flap technique | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted proximal gastrectomy with double-flap technique | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang bin, associate professor | Contact | 13798163278 | yyzsu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40789587 | Derived | 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. |
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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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| Gansu Provincial Hospital |
| OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| LanZhou University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Zunyi Medical College | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Qinghai Province Fifth People's Hospital | OTHER |
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|
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 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
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