Gastrointestinal Stromal Tumor of StomachNCT03238820

Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study

A study testing Robotic gastric gastrointestinal stromal tumors resection in people with Gastrointestinal Stromal Tumor of Stomach, run by JIANG Zhi-Wei at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Patients with gastric gastrointestinal stromal tumors will receive robotic resection. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastrointestinal Stromal Tumor of Stomach
What is being tested?: Robotic gastric gastrointestinal stromal tumors resection
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 10 Jan 2014to 1 Jun 2017
Phase: Interventional
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
American Society of Anesthesiologists (ASA) physical status I-III.
Participants can follow the visit plan.

Who cannot join

Patients certified by a doctor that doesn't fit to participate in this study.
Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
Patients with gastrointestinal stromal tumor with distant metastasis.
Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
Patients with gastrointestinal operations and complicated abdominal operations.
Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, Subjective Global Assessment (SGA) classification C, body mass index <18, Hb<70g/L).

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Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
Patients participated other subjects 3 months before this subject.
Sponsors or researchers directly involved in the testing or their family members.

Trial locations and contacts

1 site in 1 country.

China1 site

Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002

Other trials in China

About this study

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

Read the detailed description

Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. Approximately 60% of tumors develop in the stomach.Before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. However, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.

Conditions: Gastrointestinal Stromal Tumor of Stomach
Being tested: Robotic gastric gastrointestinal stromal tumors resection
Keywords: Gastrointestinal stromal tumors, Robot, manual suture
Medical subject headings: Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robotic gastric gastrointestinal stromal tumors resectionProcedure or surgery
Robotic gastric gastrointestinal stromal tumors resection

Study groups in NCT03238820
Study group	Role	What they receive
The robot group	Experimental	Patients undergo robotic gastric gastrointestinal stromal tumors resection. Receives: Procedure: Robotic gastric gastrointestinal stromal tumors resection

What is being measured

The primary outcome is the main question the study is designed to answer.

Complications
Intraoperative and postoperative complications
Measured: 1 month

Secondary outcomes (7)

Blood loss
Blood loss
Measured: 1 day
Operative time
Operative time
Measured: 1 day
Resection style
The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.
Measured: 1 day
Postoperative length of stay
Postoperative length of stay
Measured: 1 month
Inflammation level
Inflammation level
Measured: 1 month
Nutritional status
Nutritional status
Measured: 6 months
Body composition
Body composition
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 20141 Jun 2017

First posted3 Aug 2017
Study start10 Jan 2014
Primary completion5 Aug 2016
Study completion1 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastrointestinal Stromal Tumor of StomachStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single group, open study.
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03238820
Sponsor's protocol ID: BE2015687GIST
Status last verified: Jul 2017
First submitted: 27 Jul 2017
Last updated: 3 Aug 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The results and IPD might be considered to share in published articles.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)
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All Gastrointestinal Stromal Tumor of Stomach trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
ClinicalTrials.gov ID: NCT03238820
Acronym / sponsor ID: BE2015687GIST
Conditions: Gastrointestinal Stromal Tumor of Stomach
Keywords: Gastrointestinal stromal tumors, Robot, manual suture
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: JIANG Zhi-WeiUniversity, hospital or other
Study start: 10 Jan 2014 (actual)
Primary completion: 5 Aug 2016 (actual)
Study completion: 1 Jun 2017 (actual)
First posted: 3 Aug 2017 (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.

Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single group, open study.

Arm	Type	Receives
The robot group	Experimental	Procedure: Robotic gastric gastrointestinal stromal tumors resectionPatients undergo robotic gastric gastrointestinal stromal tumors resection.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
American Society of Anesthesiologists (ASA) physical status I-III.
Participants can follow the visit plan.

Key exclusion criteria (9 listed)

Patients certified by a doctor that doesn't fit to participate in this study.
Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
Patients with gastrointestinal stromal tumor with distant metastasis.
Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
Patients with gastrointestinal operations and complicated abdominal operations.

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
Robotic gastric gastrointestinal stromal tumors resectionRobotic gastric gastrointestinal stromal tumors resection	Procedure or surgery	The robot group

Primary outcome

Complications
Time frame: 1 month
Intraoperative and postoperative complications

7 secondary outcomes

Blood loss
Time frame: 1 day
Operative time
Time frame: 1 day
Resection style
Time frame: 1 day
Postoperative length of stay
Time frame: 1 month
Inflammation level
Time frame: 1 month
Nutritional status
Time frame: 6 months
Body composition
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
Individual participant dataSharing planned: Undecided. The results and IPD might be considered to share in published articles.

Related trials for Gastrointestinal Stromal Tumor of Stomach

RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 2
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
GIST - Gastrointestinal Stromal Tumor, GIST
Active, not recruitingPhase 2
Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)
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RecruitingObservational study
Integrated Cancer Repository for Cancer Research
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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.

Zhi-Wei JIANG, Ph.D. principal investigator

Jinling Hospital, Medical School of Nanjing University

Jian ZHAO, Ph.D. study director

Jinling Hospital, Medical School of Nanjing University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Robotic gastric gastrointestinal stromal tumors resection in people with Gastrointestinal Stromal Tumor of Stomach, run by JIANG Zhi-Wei 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 4 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: finished, as of the sponsor's last update on 3 Aug 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complications (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03238820.

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 3 Aug 2017.