Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

Gastric Cancer Clinical Trial

Official title:

Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874871
• Other study ID #: 2018KT86
• Status: Recruiting
• Start date: March 20, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2021
• Source: Peking University
• Contact: Rulin Miao, MD
• Phone: 86-10-88196598
• Email: miaorulin[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastrostomy
• Stomach Neoplasms

Intervention

Procedure:
• Function preserving gastrectomy
Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.
• Standard gastrectomy
Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
Peking University	Beijing Friendship Hospital, Beijing Hospital, Beijing Municipal Science & Technology Commission, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University People's Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result.	30 days after surgery
Secondary	Extent of lymphadenectomy of different gastrectomy	resected lymph node number	30 days after surgery
Secondary	Distribution of metastatic lymph node	metastatic lymph node number	30 days after surgery
Secondary	postoperative morbidity	postoperative complication rate according to the clavien-dindo classification	30 days after surgery
Secondary	postoperative mortality	postoperative death rate with 30 days	30 days after surgery
Secondary	remnant stomach function	volume of remnant stomach	3 years after surgery
Secondary	disease free survival	disease free survival after surgery	3 years after surgery
Secondary	Quality of life after surgery	Quality of life evaluated by EORTC-STO22 by questionnaire	3 years after surgery
Secondary	overall survival	overall survival after surgery	3 years after surgery