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| Name | Class |
|---|---|
| First Hospital of China Medical University | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
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Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is up to 62%, 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 status than total gastrectomy.
Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach, which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016. It can reduce the occurrence of reflux oesophagitis. At present, the studies for double-flap technique in China and other countries are mostly retrospective studies, and there are short of large-scale prospective studies and evidence of evidence-based medicine.
The applicant has initiated a phase II, single center, single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer. To further validate the short and long-term outcomes of this procedure, a multicentre, open label, prospective, superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer. It include 216 patients with proximal early gastric cancer. The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The short and long-term oncological outcomes are also explored. This trial can provide high-grade evidence of evidence-based medicine for double-flap technique's clinical applications .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Proximal Gastrectomy With Double-flap Technique | Experimental |
| |
| Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Proximal Gastrectomy With Double-flap Technique | Procedure | Patients in this group receive laparoscopic 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 esophagogastric 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 are 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 | |
|---|---|---|---|---|
| Han Fanhai, Professor | Contact | +86-135-8031-7677 | fh_han@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38964794 | Derived | Zhou S, Xie Y, Zhu Y, Tan J, Yang B, Zhong L, Zhong G, Han F. Comparing the antireflux effect of laparoscopic proximal gastrectomy with double-flap technique reconstruction versus laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer: study protocol for a multicentre, prospective, open-label, randomised controlled trial. BMJ Open. 2024 Jul 4;14(7):e079940. doi: 10.1136/bmjopen-2023-079940. |
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| Sichuan Provincial People's Hospital |
| OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Zunyi Medical College | OTHER |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| Gansu Provincial Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Qinghai Province Fifth People's Hospital | OTHER |
| LanZhou University | OTHER |
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| Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction | Procedure | Patients in this group receive laparoscopic total gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p；D2 for stage IB: Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p and 11d, 12a). The Roux-en-Y esophagojejunostomy method is used for the esophagojejunal reconstruction. |
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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 hemoglobin levels at Follow-up | blood hemoglobin(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. |
| Changes in Vitamin B12 levels at Follow-up | blood Vitamin B12（μg/ml) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. |
| Changes in total protein levels at Follow-up | blood total protein(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. |
| Changes in serum albumin levels at Follow-up | blood serum albumin(g/L) levels | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. |
| Changes in prealbumin levels at Follow-up | blood prealbumin(g/L) 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(ml) during surgery | 24 hours postoperatively |
| 3-year disease-free survival rate | 3-year disease-free survival rate | 3 years |
| 3-year overall survival rate | 3-year overall survival rate | 3 years |
| 3-year recurrence pattern | 3-year recurrence pattern | 3 years |
| 5-year disease-free survival rate | 5-year disease-free survival rate | 5 years |
| 5-year overall survival rate | 5-year overall survival rate | 5 years |
| 5-year recurrence pattern | 5-year recurrence pattern | 5 years |
| body mass index postoperatively | body mass index(kg/m^2) | Follow-up evaluations are performed 3, 6 and 12 months 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 |
| Postoperative pain assessment | We measured the pain score using visual analog scale(VAS) at 24 hours after the surgery is completed. Higher scores mean a worse outcome. | Day 1 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 |
| Pathological Characteristics | R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor. | 1 week 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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