Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

Peking University

Status: Enrolling

Conditions: Gastric Cancer; Gastrostomy

Treatments: Procedure: Function preserving gastrectomy; Procedure: Standard gastrectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03874871

2018KT86

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Function preserving gastrectomy

Description:

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.

Treatment:

Procedure: Function preserving gastrectomy

Standard gastrectomy

Description:

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.

Treatment:

Procedure: Standard gastrectomy