Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
- Conditions
- GastrostomyGastric Cancer
- Interventions
- Procedure: Function preserving gastrectomyProcedure: Standard gastrectomy
- Registration Number
- NCT03874871
- Lead Sponsor
- Peking University
- Brief Summary
The real world based multi-cohorts study aims to evaluate the safety and effectiveness of function preserving gastrectomy including pylorus-preserving distal gastrectomy, proximal gastrectomy and wedge gastrectomy for T1 and T2 gastric cancer patients.
- Detailed Description
Gastric cancer patients with clinical stage T1/2 will be screened for the study. For the patients enrolled, a multidisciplinary discussion will be performed to evaluate the proper gastrectomy for the patients and functional preserving gastrectomy will be considered for the indicated patients. For patients not proper for functional preserving gastrectomy, standard gastrectomies will be suggested. After surgery, a close follow up will be performed. During the study, a thorough data collection will be performed to evaluate the safety and effectiveness of functional preserving gastrectomy and recovery and postoperative function of remnant stomach.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Karnofsky performance over 70%
- Histologically proven gastric or gastroesophageal joint adenocarcinoma with clinical stage T1-2N0-3M0
- No severe comorbidity with estimated survival less than 5 years
- pregnancy
- Signs of distant metastases
- received chemotherapy, radiotherapy, immune therapy
- received gastrectomy
- other malignant tumors within 5 years except for cured skin cancer and cervical caner in situ.
- uncontrolled epilepsy, central nervus system disease or mental disease that affect the compliance of treatment and follow-up
- severe heart disease
- organ transplantation that needs immunosuppressor
- emergency surgery due to hemorrhage, perforation and ileus of gastric cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Function preserving gastrectomy Function preserving gastrectomy After baseline evaluation, a multidisciplinary discussion will be performed for the patients to choose the proper gastrectomy. For patients indicated for function preserving gastrectomy (including pylorus preserving gastrectomy, proximal gastrectomy, partial gastrectomy), they will receive the function preserving gastrectomy. After the surgery, a close follow up is performed. Standard gastrectomy Standard gastrectomy After baseline evaluation, a multidisciplinary discussion will be performed for the patients to choose the proper gastrectomy. For patients not indicated for function preserving gastrectomy, they will receive standard gastrectomy. After the surgery, a close follow up is performed.
- Primary Outcome Measures
Name Time Method R0 resection rate 30 days after surgery Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result.
- Secondary Outcome Measures
Name Time Method Distribution of metastatic lymph node 30 days after surgery metastatic lymph node number
Quality of life after surgery 3 years after surgery Quality of life evaluated by EORTC-STO22 by questionnaire
postoperative morbidity 30 days after surgery postoperative complication rate according to the clavien-dindo classification
disease free survival 3 years after surgery disease free survival after surgery
overall survival 3 years after surgery overall survival after surgery
remnant stomach function 3 years after surgery volume of remnant stomach
Extent of lymphadenectomy of different gastrectomy 30 days after surgery resected lymph node number
postoperative mortality 30 days after surgery postoperative death rate with 30 days
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China