LaparoscopicNCT04295473
Reduced Port Laparoscopic Gastrectomy for Gastric Cancer
A study testing Reduced port laparoscopic gastrectomy in people with Laparoscopic and Gastrectomy, run by Nanchong Central Hospital at 1 site in China.
Trial summary
Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laparoscopic, Gastrectomy
- What is being tested?
- Reduced port laparoscopic gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2020to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
Who cannot join
- Patients had distant metastasis.
- oesophageal invasion of more than 3 cm.
- Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- Previous chemotherapy or radiation therapy for any other malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunhong Tian
Nanchong, Sichuan, 637000
Yunhong Tian, Doctor, +8613508087719, drtianyunhong@126.com
About this study
Official title: Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy
Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy
Read the detailed description
Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.
- Conditions
- Laparoscopic, Gastrectomy
- Being tested
- Reduced port laparoscopic gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced port laparoscopic gastrectomyProcedure or surgery
The ports were reduced in the surgery of intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Reduced port laparoscopic gastrectomy | Experimental | The definition of reduced port laparoscopic gastrectomy was 1-3 ports used in laparoscopic gastrectomy for gastric cancer. Receives: Procedure: Reduced port laparoscopic gastrectomy |
| Standard laparoscopic gastrectomy | No intervention | 5 ports were used in standard laparoscopic gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year survival rate
Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy
Measured: 5 years
3-year survival rate
Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
Measured: 3 years
Secondary outcomes (3)
Postoperative morbidity rate
Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
Measured: 6 months
Malnutrition rate
Malnutrition rate for patients with gastrectomy after reduced port
Measured: 6 months
Quality of life in PGSAS-45 scale
The quality of life were assessed using PGSAS-45 scale for patients with gastrectomy after reduced port laparoscopic gastrectomy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start2 Mar 2020
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yunhong Tian, Nanchong Central Hospital
- Investigators
- Yunhong Tian, MD, Principal investigator, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295473
- Sponsor's protocol ID
- 2020002
- Status last verified
- May 2025
- First submitted
- 29 Feb 2020
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT04295473
- Acronym / sponsor ID
- 2020002
- Conditions
- Laparoscopic, Gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Mar 2020 (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.
Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy
Detailed description
Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced port laparoscopic gastrectomy | Experimental | Procedure: Reduced port laparoscopic gastrectomyThe definition of reduced port laparoscopic gastrectomy was 1-3 ports used in laparoscopic gastrectomy for gastric cancer. |
| Standard laparoscopic gastrectomy | No intervention | –5 ports were used in standard laparoscopic gastrectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
Key exclusion criteria (4 listed)
- Patients had distant metastasis.
- oesophageal invasion of more than 3 cm.
- Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- Previous chemotherapy or radiation therapy for any other malignancies.
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 |
|---|---|---|
| Reduced port laparoscopic gastrectomyThe ports were reduced in the surgery of intervention arm. | Procedure or surgery | Reduced port laparoscopic gastrectomy |
Primary outcome
5-year survival rate
Time frame: 5 years
Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy
3-year survival rate
Time frame: 3 years
Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy
3 secondary outcomes
Postoperative morbidity rate
Time frame: 6 months
Malnutrition rate
Time frame: 6 months
Quality of life in PGSAS-45 scale
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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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.
Yunhong Tian, MD principal investigator
Nanchong Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced port laparoscopic gastrectomy in people with Laparoscopic and Gastrectomy, run by Nanchong Central Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 21 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunhong Tian, MD (+86-13508087719, drtianyunhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year survival rate (time frame: 5 years). The study lists 2 primary outcomes in all. 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 21 May 2025.