Stomach Neoplasms
Conditions
Keywords
laparoscopy, minimally invasive surgical procedures, stomach neoplasm, Gastrectomy, Reflux Esophagitis
Brief summary
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 .
Interventions
PROCEDURELaparoscopic Proximal Gastrectomy With Double-flap Technique
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.
PROCEDURELaparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
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.
Sponsors
First Hospital of China Medical University
Tianjin Medical University Cancer Institute and Hospital
Liaoning Cancer Hospital & Institute
Sichuan Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Qilu Hospital of Shandong University
First Affiliated Hospital of Kunming Medical University
First Affiliated Hospital of Guangxi Medical University
Zunyi Medical College
Sichuan Cancer Hospital and Research Institute
Gansu Provincial Hospital
Shandong Provincial Hospital
The First Affiliated Hospital of Zhengzhou University
Qinghai Province Cancer Hospital
LanZhou University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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(AJCC) staging system(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography) 5. scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or laparoscopic total 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; The patient's cardiopulmonary function can tolerate laparoscopic surgery. 7. The patients have signed the informed consent form.
Exclusion criteria
1. history of upper abdominal surgery (except laparoscopic cholecystectomy); 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. require simultaneous surgery due to complicated with other diseases 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 are 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 hemoglobin levels at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood hemoglobin(g/L) levels |
| Changes in Vitamin B12 levels at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood Vitamin B12（μg/ml) levels |
| Changes in total protein levels at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood total protein(g/L) levels |
| Changes in serum albumin levels at Follow-up | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | blood serum albumin(g/L) levels |
| Changes in prealbumin levels 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. |
| Postoperative pain assessment | Day 1 postoperatively | We measured the pain score using visual analog scale(VAS) at 24 hours after the surgery is completed. Higher scores mean a worse outcome. |
| 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. |
| Short-term Clinical Outcome After Surgery | From surgery to discharge, up to 30 days | time to pass gas(hours) |
| Surgical Characteristics | 24 hours postoperatively | operative time(minutes) |
| 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. |
| 3-year overall survival rate | 3 years | 3-year overall survival rate |
| 3-year recurrence pattern | 3 years | 3-year recurrence pattern |
| 5-year disease-free survival rate | 5 years | 5-year disease-free survival rate |
| 5-year overall survival rate | 5 years | 5-year overall survival rate |
| 5-year recurrence pattern | 5 years | 5-year recurrence pattern |
| body mass index postoperatively | Follow-up evaluations are performed 3, 6 and 12 months postoperatively. | body mass index(kg/m\^2) |
| 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 | lymph nodes dissection extent for each patient in the surgery |
| 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. |
| 3-year disease-free survival rate | 3 years | 3-year disease-free survival rate |
Countries
China
Contacts
Primary ContactHan Fanhai, Professor
Outcome results
None listed