Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer
- Conditions
- Stomach Neoplasms
- Interventions
- Procedure: Laparoscopic Proximal Gastrectomy With Double-flap TechniqueProcedure: Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
- Registration Number
- NCT05890339
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 20 years ≤ age ≤ 80 years
- The primary gastric lesions were located in the proximal third of the stomach
- histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
- 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)
- 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).).
- The preoperative American Society of Anesthesiologists (ASA) physical status was I-III; The patient's cardiopulmonary function can tolerate laparoscopic surgery.
- The patients have signed the informed consent form.
- history of upper abdominal surgery (except laparoscopic cholecystectomy);
- the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
- with other malignant diseases or have suffered from other malignant diseases within 5 years
- require simultaneous surgery due to complicated with other diseases
- women are pregnant or in lactation period
- Suffering from serious mental illness
- history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic Proximal Gastrectomy With Double-flap Technique Laparoscopic Proximal Gastrectomy With Double-flap Technique - Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Short-term Clinical Outcome After Surgery From surgery to discharge, up to 30 days length of postoperative hospitalisation(days)
Changes in hemoglobin levels at Follow-up Follow-up evaluations are performed 3, 6 and 12 months postoperatively. blood hemoglobin(g/L) levels
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.
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
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.
3-year overall survival rate 3 years 3-year overall survival rate
Pathological Characteristics 1 week postoperatively R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.
Proportion of participants need to rehospitalized after surgery From surgery to discharge, up to 30 days rehospitalization rate.
Surgical Characteristics 24 hours postoperatively blood loss(ml) during surgery
5-year disease-free survival rate 5 years 5-year disease-free survival rate
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.
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.
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.
3-year recurrence pattern 3 years 3-year recurrence pattern
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)
Proportion of participants die after surgery From surgery to discharge, up to 30 days mortality rate
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 prealbumin levels at Follow-up Follow-up evaluations are performed 3, 6 and 12 months postoperatively. blood prealbumin(g/L) levels
3-year disease-free survival rate 3 years 3-year disease-free survival rate
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.
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China