Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

NCT ID: NCT03874871

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2025-03-01

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.

Conditions

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Gastric Cancer Gastrostomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Function preserving gastrectomy

Intervention Type PROCEDURE

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.

Standard gastrectomy

Intervention Type PROCEDURE

Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.

Interventions

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Function preserving gastrectomy

Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.

Intervention Type PROCEDURE

Standard gastrectomy

Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Ziyu Li, MD

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziyu Li, MD

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rulin Miao, MD

Role: CONTACT

86-10-88196598

Facility Contacts

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Rulin Miao, M.D.

Role: primary

86-10-88196598

Other Identifiers

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2018KT86

Identifier Type: -

Identifier Source: org_study_id

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