Gastric Cancer, Gastrostomy
Conditions
Keywords
gastric cancer, function preserving gastrectomy
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.
Interventions
PROCEDUREFunction preserving gastrectomy
Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.
PROCEDUREStandard gastrectomy
Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.
Sponsors
Beijing Municipal Science & Technology Commission
Peking Union Medical College Hospital
Beijing Friendship Hospital
Peking University Third Hospital
Chinese PLA General Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Hospital
Peking University People's Hospital
Peking University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 30 days after surgery | Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of metastatic lymph node | 30 days after surgery | metastatic lymph node number |
| postoperative morbidity | 30 days after surgery | postoperative complication rate according to the clavien-dindo classification |
| postoperative mortality | 30 days after surgery | postoperative death rate with 30 days |
| Extent of lymphadenectomy of different gastrectomy | 30 days after surgery | resected lymph node number |
| disease free survival | 3 years after surgery | disease free survival after surgery |
| Quality of life after surgery | 3 years after surgery | Quality of life evaluated by EORTC-STO22 by questionnaire |
| overall survival | 3 years after surgery | overall survival after surgery |
| remnant stomach function | 3 years after surgery | volume of remnant stomach |
Countries
China
Contacts
Primary ContactRulin Miao, MD
Outcome results
None listed