Gastric CancerNCT03874871
Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
An observational study of Gastric Cancer and Gastrostomy, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastrostomy
- What is being tested?
- Function preserving gastrectomy and Standard gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-advanced gastric cancer patients with the clinical stage cT1-2 that are indicated for gastrectomy
Who may be able to join
- 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
Who cannot join
- 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
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- severe heart disease
- organ transplantation that needs immunosuppressor
- emergency surgery due to hemorrhage, perforation and ileus of gastric cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Rulin Miao, M.D., 86-10-88196598, miaorulin@outlook.com
Ziyu Li, M.D.
About this study
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.
Read the 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.
- Conditions
- Gastric Cancer, Gastrostomy
- Being tested
- Function preserving gastrectomy, Standard gastrectomy
- Keywords
- gastric cancer, function preserving gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Function preserving gastrectomyProcedure or surgery
Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.
Standard gastrectomyProcedure or surgery
Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result.
Measured: 30 days after surgery
Secondary outcomes (8)
Extent of lymphadenectomy of different gastrectomy
resected lymph node number
Measured: 30 days after surgery
Distribution of metastatic lymph node
metastatic lymph node number
Measured: 30 days after surgery
postoperative morbidity
postoperative complication rate according to the clavien-dindo classification
Measured: 30 days after surgery
postoperative mortality
postoperative death rate with 30 days
Measured: 30 days after surgery
remnant stomach function
volume of remnant stomach
Measured: 3 years after surgery
disease free survival
disease free survival after surgery
Measured: 3 years after surgery
Quality of life after surgery
Quality of life evaluated by EORTC-STO22 by questionnaire
Measured: 3 years after surgery
overall survival
overall survival after surgery
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start20 Mar 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Beijing Friendship Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Hospital, Peking University People's Hospital
- Responsible party
- Principal investigator, Ziyu Li, MD, Peking University
- Investigators
- Ziyu Li, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874871
- Sponsor's protocol ID
- 2018KT86
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT03874871
- Acronym / sponsor ID
- 2018KT86
- Conditions
- Gastric Cancer, Gastrostomy
- Keywords
- gastric cancer, function preserving gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Beijing Friendship Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Hospital, Peking University People's Hospital
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Function preserving gastrectomy | – | Procedure: Function preserving gastrectomyAfter 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. |
| Standard gastrectomy | – | Procedure: Standard gastrectomyAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-advanced gastric cancer patients with the clinical stage cT1-2 that are indicated for gastrectomy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Function preserving gastrectomyFunction preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy. | Procedure or surgery | Function preserving gastrectomy |
| Standard gastrectomyStandard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline. | Procedure or surgery | Standard gastrectomy |
Primary outcome
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.
8 secondary outcomes
Extent of lymphadenectomy of different gastrectomy
Time frame: 30 days after surgery
Distribution of metastatic lymph node
Time frame: 30 days after surgery
postoperative morbidity
Time frame: 30 days after surgery
postoperative mortality
Time frame: 30 days after surgery
remnant stomach function
Time frame: 3 years after surgery
disease free survival
Time frame: 3 years after surgery
Quality of life after surgery
Time frame: 3 years after surgery
overall survival
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziyu Li, MD study chair
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastrostomy, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rulin Miao, MD (86-10-88196598, miaorulin@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.