Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

Conditions
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Gastric Cancer, Gastrostomy

Intervention / Treatment
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* Procedure: Function preserving gastrectomy
* Procedure: Standard gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Function preserving gastrectomy<br>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. | Procedure: Function preserving gastrectomy<br>* Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.<br>|
| Standard gastrectomy<br>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. | Procedure: Standard gastrectomy<br>* Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of lymphadenectomy of different gastrectomy | resected lymph node number | 30 days after surgery | 
| Distribution of metastatic lymph node | metastatic lymph node number | 30 days after surgery | 
| postoperative morbidity | postoperative complication rate according to the clavien-dindo classification | 30 days after surgery | 
| postoperative mortality | postoperative death rate with 30 days | 30 days after surgery | 
| remnant stomach function | volume of remnant stomach | 3 years after surgery | 
| disease free survival | disease free survival after surgery | 3 years after surgery | 
| Quality of life after surgery | Quality of life evaluated by EORTC-STO22 by questionnaire | 3 years after surgery | 
| overall survival | overall survival after surgery | 3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, function preserving gastrectomy