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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
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.
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.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
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.
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 hemoglobin levels 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 levels at Follow-up
blood Vitamin B12（μg/ml) levels
Time frame: 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
Time frame: 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
Time frame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Changes in prealbumin levels at Follow-up
blood prealbumin(g/L) 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(ml) during surgery
Time frame: 24 hours postoperatively
3-year disease-free survival rate
3-year disease-free survival rate
Time frame: 3 years
3-year overall survival rate
3-year overall survival rate
Time frame: 3 years
3-year recurrence pattern
3-year recurrence pattern
Time frame: 3 years
5-year disease-free survival rate
5-year disease-free survival rate
Time frame: 5 years
5-year overall survival rate
5-year overall survival rate
Time frame: 5 years
5-year recurrence pattern
5-year recurrence pattern
Time frame: 5 years
body mass index postoperatively
body mass index(kg/m\^2)
Time frame: 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.
Time frame: 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.
Time frame: Day 1 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
Pathological Characteristics
R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.
Time frame: 1 week 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
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