NCT03874871

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

March 4, 2019

Last Update Submit

April 6, 2021

Conditions

Gastric CancerGastrostomy

Keywords

gastric cancerfunction preserving gastrectomy

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result.

    30 days after surgery

Secondary Outcomes (8)

  • Extent of lymphadenectomy of different gastrectomy

    30 days after surgery

  • Distribution of metastatic lymph node

    30 days after surgery

  • postoperative morbidity

    30 days after surgery

  • postoperative mortality

    30 days after surgery

  • remnant stomach function

    3 years after surgery

  • +3 more secondary outcomes

Study Arms (2)

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

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

Interventions

Function preserving gastrectomyPROCEDURE

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

Function preserving gastrectomy
Standard gastrectomyPROCEDURE

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

Standard gastrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Ziyu Li, MD

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Central Study Contacts

Rulin Miao, MD

CONTACT

86-10-88196598miaorulin@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 14, 2019

Study Start

March 20, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2025

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)