Colorectal Cancer MetastaticNCT03193710
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved
An observational study of Colorectal Cancer Metastatic and Survival Rate, run by Guizhi Du at 1 site in China.
Trial summary
The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer Metastatic, Survival Rate, General Anesthetics Toxicity
- What is being tested?
- Propofol, Sevoflurane and Remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to Oct 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colonal or rectal cancer undergoing cancer resection with general anesthesia
Who may be able to join
- All the patients diagnosed with colonal or rectal cancer
- Aged 18-65
- ASA I-III
- Assigned to receive resection surgery under general anesthesia, with an expected duration of 2 hours or more
- Agree to participate and give signed written informed consent.
Who cannot join
- Severe organic heart, liver and kidney diseases
- Diabetes or hemopoietic disorders
- Allergy to general anesthetics
- Family historical malignant hyperthermia
- Cognition dysfunction
- End-stage cancer or with over 2 cancer metastasis, pathological results were benign tumor or TNM stage was over T1- 3N0 - 2M0
Show all 10Show fewer
- Other primary malignant tumor
- Immune deficiency or dysfunction or autoimmune disease or long-term usage of corticoids or immunosuppressants
- Receiving general anesthesia within the last 3 months before the resection surgery
- Perioperative transfusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University, Department of Anesthesiology
Chengdu, Sichuan, 610041
Guizhi Du, MD, PhD, +86-189-8060-2213, du_guizhi@yahoo.com
Guizhi Du, MD, PhD
About this study
Official title: Comparison of the Effects of Total Intravenous Anesthesia and Inhalation Anesthesia on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and the Mechanism Involved: a Single-center, Randomized, Prospective Study
The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.
Read the detailed description
With the increasing number of patients diagnosed with colorectal cancer, the proportion of patients undergoing surgical resection with general anesthesia increased. However, the operation can lead tumor cells releasing into the blood or peritoneal implantation, and the impaired immune response can make patients susceptible to the development of tumor metastasis and recurrence which is the the main reason of death. It is well known that B lymphocytes and T lymphocytes are the main immune cells, and B lymphocytes by secreting antibodies are related to humoral immunity and T lymphocytes which play the most important role in antitumor are related to cell-mediated immunity. Surgery stress leads to metabolic and neuroendocrine changes causing significant depression of immunity. Although general anesthesia could reduce surgical stress, studies indicated general anesthetics including intravenous and inhalational agents both have variable effects on tumor cells growth by immuno-modulation and some cytokines. A number of studies have demonstrated deleterious effects on the function of lymphocytes associated with the administration of volatile inhalational anesthetic agents. It was suggested that the use of volatile inhalational agent may augment tumor cells growth by inhibiting the activity of lymphocytes, NK cells and dendritic cells which are important for recognizing, capturing and killing tumor cells, however, the alternative propofol has a converse (beneficial) effect by decreasing the plasma level of cytokines secreted by activated lymphocytes, macrophages and NK cells. The detailed mechanism of how volatile anesthetics affect the activity of antitumor cells remains unknown. Thus the investigators will conduct the clinical investigation to study the effect of volatile anesthetics on the immune response and metastasis in patients undergoing colorectal cancer resection, exploring molecular mechanism involved if inhalational anesthetics show an effect. The findings of this study would be valuable for anesthetic regimen guidance of colorectal cancer patients undergoing surgical resection in terms of long-term survival.
- Conditions
- Colorectal Cancer Metastatic, Survival Rate, General Anesthetics Toxicity, Lymphocyte Destruction, Molecular Mechanism of Pharmacological Action
- Being tested
- Propofol, Sevoflurane, Remifentanil
- Keywords
- Intravenous anesthesia, Inhalational anesthesia, Colorectal cancer resection, Lymphocytes, Metastasis, Survival, Molecular mechanism
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.
SevofluraneDrug
Also called Abbvie
Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.
RemifentanilDrug
Also called YiChang HumanWell Pharmaceutical Co.，LTD. China
Remifentanil will be used for analgesia in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia group | The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil. Receives: Drug: Propofol; Drug: Remifentanil | |
| Inhalational anesthesia group | The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil. Receives: Drug: Sevoflurane; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline lymphocytes within postoperative 5 years
Blood will be drawn preoperatively ( at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CD4+/CD8+, B lymphocytes, dendritic cells, natural killer cells
Measured: up to 5 years
Cancer free survival
Patients who remain alive without known colonal or rectal tumor recurrence
Measured: 5 years or as available
Secondary outcomes (9)
Cancer recurrence rate
Patients who remain alive with known colonal or rectal tumor recurrence
Measured: up to 5 years
Cancer metastasis rate
Patients who remain alive with known colonal or rectal tumor metastasis
Measured: up to 5 years
Re-operation
Patients who have a surgery under general anesthesia
Measured: up to 5 years
Anesthesia scheme for re-operation
Total intravenous anesthesia, inhalational anesthesia or combined anesthesia
Measured: up to 5 years
Radiotherapy rate for any cancer
Patients have radiotherapy for any cancer
Measured: up to 5 years
Chemotherapy rate for any cancer
Patients have chemotherapy for any cancer
Measured: up to 5 years
Circulating tumor cells
Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing circulating tumor cells
Measured: up to 5 years
Concentration of cytokines
Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing IL, TNF-α, IFN-γ and GCSF
Measured: up to 5 years
Colorectal cancer antibodies
Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CEA, CA199, GP87 and TPA.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Sep 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhi Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guizhi Du, West China Hospital
- Investigators
- Jin Liu, MD, PhD, Study chair, Department of Anesthesiology, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193710
- Sponsor's protocol ID
- WestChinaHospital
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All the study outcomes
Publications
Sofra M, Fei PC, Fabrizi L, Marcelli ME, Claroni C, Gallucci M, Ensoli F, Forastiere E. Immunomodulatory effects of total intravenous and balanced inhalation anesthesia in patients with bladder cancer undergoing elective radical cystectomy: preliminary results. J Exp Clin Cancer Res. 2013 Feb 3;32(1):6. doi: 10.1186/1756-9966-32-6.
PubMed 23374147Qiao Y, Feng H, Zhao T, Yan H, Zhang H, Zhao X. Postoperative cognitive dysfunction after inhalational anesthesia in elderly patients undergoing major surgery: the influence of anesthetic technique, cerebral injury and systemic inflammation. BMC Anesthesiol. 2015 Oct 23;15:154. doi: 10.1186/s12871-015-0130-9.
PubMed 26497059Moller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate: a double-blind, randomized, clinical trial. Br J Anaesth. 2013 Mar;110(3):388-96. doi: 10.1093/bja/aes416. Epub 2012 Nov 19.
PubMed 23166149Jaura AI, Flood G, Gallagher HC, Buggy DJ. Differential effects of serum from patients administered distinct anaesthetic techniques on apoptosis in breast cancer cells in vitro: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i63-7. doi: 10.1093/bja/aet581. Epub 2014 Jul 9.
PubMed 25009197Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.
PubMed 25009196Wigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016 Jan;124(1):69-79. doi: 10.1097/ALN.0000000000000936.
PubMed 26556730Woo JH, Baik HJ, Kim CH, Chung RK, Kim DY, Lee GY, Chun EH. Effect of Propofol and Desflurane on Immune Cell Populations in Breast Cancer Patients: A Randomized Trial. J Korean Med Sci. 2015 Oct;30(10):1503-8. doi: 10.3346/jkms.2015.30.10.1503. Epub 2015 Sep 12.
PubMed 26425050Bayliss DA, Barrett PQ. Emerging roles for two-pore-domain potassium channels and their potential therapeutic impact. Trends Pharmacol Sci. 2008 Nov;29(11):566-75. doi: 10.1016/j.tips.2008.07.013. Epub 2008 Sep 25.
PubMed 18823665Pei L, Tan G, Wang L, Guo W, Xiao B, Gao X, Wang L, Li H, Xu Z, Zhang X, Zhao J, Yi J, Huang Y. Comparison of combined general-epidural anesthesia with general anesthesia effects on survival and cancer recurrence: a meta-analysis of retrospective and prospective studies. PLoS One. 2014 Dec 30;9(12):e114667. doi: 10.1371/journal.pone.0114667. eCollection 2014.
PubMed 25548913Shi C, Thum C, Zhang Q, Tu W, Pelaz B, Parak WJ, Zhang Y, Schneider M. Inhibition of the cancer-associated TASK 3 channels by magnetically induced thermal release of Tetrandrine from a polymeric drug carrier. J Control Release. 2016 Sep 10;237:50-60. doi: 10.1016/j.jconrel.2016.06.044. Epub 2016 Jul 1.
PubMed 27374629
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Total Intravenous Anesthesia and Inhalation Anesthesia on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and the Mechanism Involved: a Single-center, Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT03193710
- Acronym / sponsor ID
- WestChinaHospital
- Conditions
- Colorectal Cancer Metastatic, Survival Rate, General Anesthetics Toxicity, Lymphocyte Destruction, Molecular Mechanism of Pharmacological Action
- Keywords
- Intravenous anesthesia, Inhalational anesthesia, Colorectal cancer resection, Lymphocytes, Metastasis, Survival, Molecular mechanism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Guizhi DuUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 21 Jun 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.
The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.
Detailed description
With the increasing number of patients diagnosed with colorectal cancer, the proportion of patients undergoing surgical resection with general anesthesia increased. However, the operation can lead tumor cells releasing into the blood or peritoneal implantation, and the impaired immune response can make patients susceptible to the development of tumor metastasis and recurrence which is the the main reason of death. It is well known that B lymphocytes and T lymphocytes are the main immune cells, and B lymphocytes by secreting antibodies are related to humoral immunity and T lymphocytes which play the most important role in antitumor are related to cell-mediated immunity. Surgery stress leads to metabolic and neuroendocrine changes causing significant depression of immunity. Although general anesthesia could reduce surgical stress, studies indicated general anesthetics including intravenous and inhalational agents both have variable effects on tumor cells growth by immuno-modulation and some cytokines. A number of studies have demonstrated deleterious effects on the function of lymphocytes associated with the administration of volatile inhalational anesthetic agents. It was suggested that the use of volatile inhalational agent may augment tumor cells growth by inhibiting the activity of lymphocytes, NK cells and dendritic cells which are important for recognizing, capturing and killing tumor cells, however, the alternative propofol has a converse (beneficial) effect by decreasing the plasma level of cytokines secreted by activated lymphocytes, macrophages and NK cells. The detailed mechanism of how volatile anesthetics affect the activity of antitumor cells remains unknown. Thus the investigators will conduct the clinical investigation to study the effect of volatile anesthetics on the immune response and metastasis in patients undergoing colorectal cancer resection, exploring molecular mechanism involved if inhalational anesthetics show an effect. The findings of this study would be valuable for anesthetic regimen guidance of colorectal cancer patients undergoing surgical resection in terms of long-term survival.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia group | – | Drug: Propofol, Drug: RemifentanilThe anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil. |
| Inhalational anesthesia group | – | Drug: Sevoflurane, Drug: RemifentanilThe anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colonal or rectal cancer undergoing cancer resection with general anesthesia
Key inclusion criteria (5 listed)
- All the patients diagnosed with colonal or rectal cancer
- Aged 18-65
- ASA I-III
- Assigned to receive resection surgery under general anesthesia, with an expected duration of 2 hours or more
- Agree to participate and give signed written informed consent.
Key exclusion criteria (10 listed)
- Severe organic heart, liver and kidney diseases
- Diabetes or hemopoietic disorders
- Allergy to general anesthetics
- Family historical malignant hyperthermia
- Cognition dysfunction
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 |
|---|---|---|
| PropofolAlso: DiprivanPropofol will be used for anesthesia maintenance in the total intravenous anesthesia group. | Drug | Total intravenous anesthesia group |
| SevofluraneAlso: AbbvieSevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group. | Drug | Inhalational anesthesia group |
| RemifentanilAlso: YiChang HumanWell Pharmaceutical Co.，LTD. ChinaRemifentanil will be used for analgesia in both groups. | Drug | Inhalational anesthesia group, Total intravenous anesthesia group |
Primary outcome
Change from baseline lymphocytes within postoperative 5 years
Time frame: up to 5 years
Blood will be drawn preoperatively ( at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CD4+/CD8+, B lymphocytes, dendritic cells, natural killer cells
Cancer free survival
Time frame: 5 years or as available
Patients who remain alive without known colonal or rectal tumor recurrence
9 secondary outcomes
Cancer recurrence rate
Time frame: up to 5 years
Cancer metastasis rate
Time frame: up to 5 years
Re-operation
Time frame: up to 5 years
Anesthesia scheme for re-operation
Time frame: up to 5 years
Radiotherapy rate for any cancer
Time frame: up to 5 years
Chemotherapy rate for any cancer
Time frame: up to 5 years
Circulating tumor cells
Time frame: up to 5 years
Concentration of cytokines
Time frame: up to 5 years
Colorectal cancer antibodies
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 23374147Sofra M, Fei PC, Fabrizi L, Marcelli ME, Claroni C, Gallucci M, Ensoli F, Forastiere E. Immunomodulatory effects of total intravenous and balanced inhalation anesthesia in patients with bladder cancer undergoing elective radical cystectomy: preliminary results. J Exp Clin Cancer Res. 2013 Feb 3;32(1):6. doi: 10.1186/1756-9966-32-6.
- Background: PubMed 26497059Qiao Y, Feng H, Zhao T, Yan H, Zhang H, Zhao X. Postoperative cognitive dysfunction after inhalational anesthesia in elderly patients undergoing major surgery: the influence of anesthetic technique, cerebral injury and systemic inflammation. BMC Anesthesiol. 2015 Oct 23;15:154. doi: 10.1186/s12871-015-0130-9.
- Background: PubMed 23166149Moller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate: a double-blind, randomized, clinical trial. Br J Anaesth. 2013 Mar;110(3):388-96. doi: 10.1093/bja/aes416. Epub 2012 Nov 19.
- Background: PubMed 25009197Jaura AI, Flood G, Gallagher HC, Buggy DJ. Differential effects of serum from patients administered distinct anaesthetic techniques on apoptosis in breast cancer cells in vitro: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i63-7. doi: 10.1093/bja/aet581. Epub 2014 Jul 9.
- Background: PubMed 25009196Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.
- Background: PubMed 26556730Wigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016 Jan;124(1):69-79. doi: 10.1097/ALN.0000000000000936.
- Background: PubMed 26425050Woo JH, Baik HJ, Kim CH, Chung RK, Kim DY, Lee GY, Chun EH. Effect of Propofol and Desflurane on Immune Cell Populations in Breast Cancer Patients: A Randomized Trial. J Korean Med Sci. 2015 Oct;30(10):1503-8. doi: 10.3346/jkms.2015.30.10.1503. Epub 2015 Sep 12.
- Background: PubMed 18823665Bayliss DA, Barrett PQ. Emerging roles for two-pore-domain potassium channels and their potential therapeutic impact. Trends Pharmacol Sci. 2008 Nov;29(11):566-75. doi: 10.1016/j.tips.2008.07.013. Epub 2008 Sep 25.
- Background: PubMed 25548913Pei L, Tan G, Wang L, Guo W, Xiao B, Gao X, Wang L, Li H, Xu Z, Zhang X, Zhao J, Yi J, Huang Y. Comparison of combined general-epidural anesthesia with general anesthesia effects on survival and cancer recurrence: a meta-analysis of retrospective and prospective studies. PLoS One. 2014 Dec 30;9(12):e114667. doi: 10.1371/journal.pone.0114667. eCollection 2014.
- Background: PubMed 27374629Shi C, Thum C, Zhang Q, Tu W, Pelaz B, Parak WJ, Zhang Y, Schneider M. Inhibition of the cancer-associated TASK 3 channels by magnetically induced thermal release of Tetrandrine from a polymeric drug carrier. J Control Release. 2016 Sep 10;237:50-60. doi: 10.1016/j.jconrel.2016.06.044. Epub 2016 Jul 1.
- Individual participant dataSharing planned: Yes. All the study outcomes
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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.
Jin Liu, MD, PhD study chair
Department of Anesthesiology, West China Hospital
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 Colorectal Cancer Metastatic and Survival Rate, run by Guizhi Du 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 5 inclusion and 10 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 6 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guizhi Du, MD, PhD (+8618980602213, du_guizhi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline lymphocytes within postoperative 5 years (time frame: up to 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?
On the ClinicalTrials.gov record for NCT03193710, which also lists 10 linked publications.
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 6 Nov 2017.