Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

April 6, 2021 updated by: Ziyu Li, MD, Peking University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Non-advanced gastric cancer patients with the clinical stage cT1-2 that are indicated for gastrectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 30 days after surgery
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
Time Frame: 30 days after surgery
resected lymph node number
30 days after surgery
Distribution of metastatic lymph node
Time Frame: 30 days after surgery
metastatic lymph node number
30 days after surgery
postoperative morbidity
Time Frame: 30 days after surgery
postoperative complication rate according to the clavien-dindo classification
30 days after surgery
postoperative mortality
Time Frame: 30 days after surgery
postoperative death rate with 30 days
30 days after surgery
remnant stomach function
Time Frame: 3 years after surgery
volume of remnant stomach
3 years after surgery
disease free survival
Time Frame: 3 years after surgery
disease free survival after surgery
3 years after surgery
Quality of life after surgery
Time Frame: 3 years after surgery
Quality of life evaluated by EORTC-STO22 by questionnaire
3 years after surgery
overall survival
Time Frame: 3 years after surgery
overall survival after surgery
3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

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

Investigators

  • Study Chair: Ziyu Li, MD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018KT86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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