Gastric CancerNCT04868747
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
A study testing Lidocaine and normal saline in people with Gastric Cancer, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Lidocaine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2021to 2 Apr 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of stomach cancer
- ASA class I-III
- no metastatic disease
Who cannot join
- hepatic, renal disease
- chronic inflammatory disease, eg. rheumatoid arthritis
- steroid or anti-inflammatory drug medication
- allergies to study drugs
- neuropsychiatric disease
- refusal of participation
- breast feeding or pregnancy
- weight < 40 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Lidocaine Intravenous Infusion on Neutrophil Extracellular Trapping After Surgery for Stomach Cancer
To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer
Read the detailed description
To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase
- Conditions
- Gastric Cancer
- Being tested
- Lidocaine, normal saline
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.
normal salineDrug
The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The study group receives the intravenous 1% lidocaine 1.5 mg/kg bolus followed by 1.5 mg/kg/h during surgery and 1.0 mg/kg/h until 24 hours after surgery (Max.<120 mg/h). Receives: Drug: Lidocaine |
| control group | Placebo comparator | The control group receives intravenous normal saline 0.15 ml/kg bolus followed by 0.15 ml/kg/h during surgery and 0.1 mg/kg/h until 24 hours after surgery. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum concentration of NET(neutrophil extracellular trapping)-related biomarker
NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)
Measured: 24 hours after surgery
Secondary outcomes (3)
quality of recovery
The quality of recovery is assessed using questionnaire. This questionnaire includes 15 items. The score range is from 0 to 150. The higher score means the better quality of recovery after surgery.
Measured: 24 hours after surgery
postoperative pain
The postoperative pain is assessed using numeric rating scale (NRS; 0=no pain, 10=the maximal pain)
Measured: 24 hours after surgery
survival of patients
The survival of patients is assessed using electronic medical record.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Apr 2021
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Why it stopped: due to financial problem
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Young Eun Moon, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868747
- Sponsor's protocol ID
- NET-lidocaine-stomach cancer
- Status last verified
- Jan 2023
- First submitted
- 26 Apr 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Lidocaine Intravenous Infusion on Neutrophil Extracellular Trapping After Surgery for Stomach Cancer
- ClinicalTrials.gov ID
- NCT04868747
- Acronym / sponsor ID
- NET-lidocaine-stomach cancer
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to financial problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 3 May 2021 (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.
To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer
Detailed description
To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: LidocaineThe study group receives the intravenous 1% lidocaine 1.5 mg/kg bolus followed by 1.5 mg/kg/h during surgery and 1.0 mg/kg/h until 24 hours after surgery (Max.<120 mg/h). |
| control group | Placebo comparator | Drug: normal salineThe control group receives intravenous normal saline 0.15 ml/kg bolus followed by 0.15 ml/kg/h during surgery and 0.1 mg/kg/h until 24 hours after surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of stomach cancer
- ASA class I-III
- no metastatic disease
Key exclusion criteria (8 listed)
- hepatic, renal disease
- chronic inflammatory disease, eg. rheumatoid arthritis
- steroid or anti-inflammatory drug medication
- allergies to study drugs
- neuropsychiatric disease
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 |
|---|---|---|
| LidocaineThe participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy. | Drug | study group |
| normal salineThe participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy. | Drug | control group |
Primary outcome
serum concentration of NET(neutrophil extracellular trapping)-related biomarker
Time frame: 24 hours after surgery
NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)
3 secondary outcomes
quality of recovery
Time frame: 24 hours after surgery
postoperative pain
Time frame: 24 hours after surgery
survival of patients
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
Young Eun Moon, MD principal investigator
Seoul St. Mary's 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 Lidocaine and normal saline in people with Gastric Cancer, run by The Catholic University of Korea at 1 site in South Korea.
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 8 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: withdrawn, as of the sponsor's last update on 12 Jan 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
serum concentration of NET(neutrophil extracellular trapping)-related biomarker (time frame: 24 hours 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 12 Jan 2023.