Crohn's DiseaseESPRITNCT02716454
Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease
A study testing Ileocaecal resection in people with Crohn's Disease, run by Ondrej Ryska at 12 sites in Czechia.
Trial summary
This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Ileocaecal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesCzechia
- Study dates
- May 2016to Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18-65 years with a uncomplicated ileocaecal form of Crohn's disease (affected < 20 cm of terminal ileum) (type: L1B1) diagnosed within last 12 months
- Diagnose confirmed by endoscopy including appropriate extent of disease and presence of ulcers in terminal ileum
- Patient is able to understand the study and sign an informed consent
Who cannot join
- Pregnant or breastfeeding women
- Previous bowel resection or other extensive abdominal surgery, which primarily excludes laparoscopic approach
- Affected other parts of the digestive tract or symptomatic stenosis or stenosis impassable for the endoscope or presence of prestenotic dilatation in terminal ileum confirmed by enterography
- Any extraluminal complications of Crohn's disease (fistula, abscess)
- Affected part of terminal ileum longer than 20 cm
- Severe comorbidities (heart failure, renal failure, liver failure, severe disorders of the central and peripheral nervous system, serious infectious disease) or patient with ASA (American Society of Anesthesiologists) III and more
Show all 13Show fewer
- Malnutrition or presence of another serious risk factor, which contradicts construction of primary anastomosis
- Current use of immunosuppressive or biologic therapy
- Other exclusion criteria:
- Different intraoperative finding
- Protocol violation
- Subject refuses further participation in the study
- Termination of the trial by responsible authority
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Czechia12 sites
The University Hospital Brno
Brno, 625 00
Lenka Prokopova, Dr., lprokopova@fnbrno.cz
Filip Marek, Dr., fmarek@fnbrno.cz
Hospital Ceske Budejovice
České Budějovice, 370 01
Olga Shonova, Dr., shonova@nemcb.cz
M Kobza, Dr., mkobza@seznam.cz
Horovice Hospital
Hořovice, 26831
Zuzana Serclova, Dr, sercl@seznam.cz
Universitiy Hospital Hradec Kralove
Hradec Králové, 50005
Julius Orhalmi, Dr., orhalmi@volny.cz
Hospital Jihlava
Jihlava, 586 33
Marie Tomanova, Dr., tomanovam@nemji.cz
Hospital Liberec
Liberec, 460 63
Lenka Nedbalova, Dr., lenka.nedbalova@nemlib.cz
Vitkovice Hospital
Ostrava - Vitkovice, 703 84
University Hospital in Pilsen
Pilsen, 323 18
Jana Kozeluhova, Dr., kozeluhova@fnplzen.cz
Royal Vinohrady University Hospital
Prague, 100 34
Pavel Lisý, Dr., lisy@fnkv.cz
Institute for Clinical and Experimental Medicine
Prague, 140 21
Pavel Drastich, Dr., drastich@hotmail.com
Na Homolce Hospital
Prague, 150 00
Karel Mareš, Dr, karel.mares@homolka.cz
ISCARE
Prague, 170 00
Dana Duricova, Dr, dana.duricova@seznam.cz
About this study
Official title: Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study
This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy.
Read the detailed description
Surgical therapy is currently indicated for Crohn's disease (CD) patients after conservative treatment becomes ineffective. The principles of so-called step-up therapy (STUP) where surgery represents the last therapeutical option are still followed.
Early surgical intervention (Early Surgery - ES) can be an alternative even in patients with uncomplicated type of CD before all medical therapy is used (Top-down approach). Limited resection under these conditions will lead to immediate remission. Moreover, laparoscopic ileocaecal resection is safe with low morbidity and regarding potential complications of step-up treatment might be beneficial for the patient.
Before wide introduction of ES approach into clinical practice, it is necessary to perform a randomized trial comparing early resection with the standard step-up medical therapy.
The potential effect of early, intensive therapy (ileocaecal resection) on biological behavior of the disease has not been studied that is why patients with uncomplicated ileocaecal form are the most suitable for such a trial. Significant number of these patients will indeed progress into more unfavorable course of the disease (relapse, complicated form, early recurrence).
Other potential benefit of early resection is the extended period without necessary medication. Even pharmacological recurrence prevention is not needed after surgery in uncomplicated CD patient if other risk factors are excluded. Rapid remission induced by surgery can lead to faster improvement of quality of life than long-term medication.
- Conditions
- Crohn's Disease
- Being tested
- Ileocaecal resection
- Keywords
- Early surgery, Crohn's disease, Step-up therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileocaecal resectionProcedure or surgery
laparoscopic ileocaecal resection with primary anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Early Surgery - ES | Experimental | Early laparoscopic ileocaecal resection Receives: Procedure: Ileocaecal resection |
| Step-up therapy - STUP | No intervention | Treatment with step-up conservative approach according to good clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic remission
The rate of endoscopic remission defined as Rutgeerts score ≤ 1 and SES-CD = 0 in early surgery and standard step-up therapy group respectively
Measured: 24 months
Secondary outcomes (3)
QoL
Quality of life measured by IBDQ, IBD Disability index
Measured: 24 months
Clinical remission
Clinical remission defined by Crohn's disease activity index < 150
Measured: 24 months
Drug consumption
Overall drug consumption (corticosteroids, antibiotics, immunomodulators, biologic therapy)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (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 Crohn's DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondrej Ryska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ondrej Ryska, Czech Surgical Society
- Investigators
- Ondrej Ryska, Dr, PhD, Principal investigator, Section of IBD surgery - Czech Surgical Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716454
- Sponsor's protocol ID
- IBDchirCZ-01
- Acronym
- ESPRIT
- Status last verified
- Apr 2016
- First submitted
- 17 Mar 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jess T, Riis L, Vind I, Winther KV, Borg S, Binder V, Langholz E, Thomsen OO, Munkholm P. Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark. Inflamm Bowel Dis. 2007 Apr;13(4):481-9. doi: 10.1002/ibd.20036.
PubMed 17206705Domenech E, Zabana Y, Garcia-Planella E, Lopez San Roman A, Nos P, Ginard D, Gordillo J, Martinez-Silva F, Beltran B, Manosa M, Cabre E, Gassull MA. Clinical outcome of newly diagnosed Crohn's disease: a comparative, retrospective study before and after infliximab availability. Aliment Pharmacol Ther. 2010 Jan 15;31(2):233-9. doi: 10.1111/j.1365-2036.2009.04170.x. Epub 2009 Oct 13.
PubMed 19832727Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294.
PubMed 15647188Golovics PA, Lakatos L, Nagy A, Pandur T, Szita I, Balogh M, Molnar C, Komaromi E, Lovasz BD, Mandel M, Veres G, Kiss LS, Vegh Z, Lakatos PL. Is early limited surgery associated with a more benign disease course in Crohn's disease? World J Gastroenterol. 2013 Nov 21;19(43):7701-10. doi: 10.3748/wjg.v19.i43.7701.
PubMed 24282358Eshuis EJ, Bemelman WA, van Bodegraven AA, Sprangers MA, Bossuyt PM, van Milligen de Wit AW, Crolla RM, Cahen DL, Oostenbrug LE, Sosef MN, Voorburg AM, Davids PH, van der Woude CJ, Lange J, Mallant RC, Boom MJ, Lieverse RJ, van der Zaag ES, Houben MH, Vecht J, Pierik RE, van Ditzhuijsen TJ, Prins HA, Marsman WA, Stockmann HB, Brink MA, Consten EC, van der Werf SD, Marinelli AW, Jansen JM, Gerhards MF, Bolwerk CJ, Stassen LP, Spanier BW, Bilgen EJ, van Berkel AM, Cense HA, van Heukelem HA, van de Laar A, Slot WB, Eijsbouts QA, van Ooteghem NA, van Wagensveld B, van den Brande JM, van Geloven AA, Bruin KF, Maring JK, Oldenburg B, van Hillegersberg R, de Jong DJ, Bleichrodt R, van der Peet DL, Dekkers PE, Goei TH, Stokkers PC. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial). BMC Surg. 2008 Aug 22;8:15. doi: 10.1186/1471-2482-8-15.
PubMed 18721465Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6.
PubMed 2394349Peyrin-Biroulet L, Cieza A, Sandborn WJ, Coenen M, Chowers Y, Hibi T, Kostanjsek N, Stucki G, Colombel JF; International Programme to Develop New Indexes for Crohn's Disease (IPNIC) group. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut. 2012 Feb;61(2):241-7. doi: 10.1136/gutjnl-2011-300049. Epub 2011 Jun 5.
PubMed 21646246Dignass A, Van Assche G, Lindsay JO, Lemann M, Soderholm J, Colombel JF, Danese S, D'Hoore A, Gassull M, Gomollon F, Hommes DW, Michetti P, O'Morain C, Oresland T, Windsor A, Stange EF, Travis SP; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis. 2010 Feb;4(1):28-62. doi: 10.1016/j.crohns.2009.12.002. Epub 2010 Jan 15. No abstract available.
PubMed 21122489Maartense S, Dunker MS, Slors JF, Cuesta MA, Pierik EG, Gouma DJ, Hommes DW, Sprangers MA, Bemelman WA. Laparoscopic-assisted versus open ileocolic resection for Crohn's disease: a randomized trial. Ann Surg. 2006 Feb;243(2):143-9; discussion 150-3. doi: 10.1097/01.sla.0000197318.37459.ec.
PubMed 16432345Aratari A, Papi C, Leandro G, Viscido A, Capurso L, Caprilli R. Early versus late surgery for ileo-caecal Crohn's disease. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1303-12. doi: 10.1111/j.1365-2036.2007.03515.x. Epub 2007 Sep 10.
PubMed 17848181
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02716454
- Acronym / sponsor ID
- ESPRIT / IBDchirCZ-01
- Conditions
- Crohn's Disease
- Keywords
- Early surgery, Crohn's disease, Step-up therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ondrej RyskaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- 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.
This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy.
Detailed description
Surgical therapy is currently indicated for Crohn's disease (CD) patients after conservative treatment becomes ineffective. The principles of so-called step-up therapy (STUP) where surgery represents the last therapeutical option are still followed.
Early surgical intervention (Early Surgery - ES) can be an alternative even in patients with uncomplicated type of CD before all medical therapy is used (Top-down approach). Limited resection under these conditions will lead to immediate remission. Moreover, laparoscopic ileocaecal resection is safe with low morbidity and regarding potential complications of step-up treatment might be beneficial for the patient.
Before wide introduction of ES approach into clinical practice, it is necessary to perform a randomized trial comparing early resection with the standard step-up medical therapy.
The potential effect of early, intensive therapy (ileocaecal resection) on biological behavior of the disease has not been studied that is why patients with uncomplicated ileocaecal form are the most suitable for such a trial. Significant number of these patients will indeed progress into more unfavorable course of the disease (relapse, complicated form, early recurrence).
Other potential benefit of early resection is the extended period without necessary medication. Even pharmacological recurrence prevention is not needed after surgery in uncomplicated CD patient if other risk factors are excluded. Rapid remission induced by surgery can lead to faster improvement of quality of life than long-term medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Surgery - ES | Experimental | Procedure: Ileocaecal resectionEarly laparoscopic ileocaecal resection |
| Step-up therapy - STUP | No intervention | –Treatment with step-up conservative approach according to good clinical practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients aged 18-65 years with a uncomplicated ileocaecal form of Crohn's disease (affected < 20 cm of terminal ileum) (type: L1B1) diagnosed within last 12 months
- Diagnose confirmed by endoscopy including appropriate extent of disease and presence of ulcers in terminal ileum
- Patient is able to understand the study and sign an informed consent
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding women
- Previous bowel resection or other extensive abdominal surgery, which primarily excludes laparoscopic approach
- Affected other parts of the digestive tract or symptomatic stenosis or stenosis impassable for the endoscope or presence of prestenotic dilatation in terminal ileum confirmed by enterography
- Any extraluminal complications of Crohn's disease (fistula, abscess)
- Affected part of terminal ileum longer than 20 cm
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 |
|---|---|---|
| Ileocaecal resectionlaparoscopic ileocaecal resection with primary anastomosis | Procedure or surgery | Early Surgery - ES |
Primary outcome
Endoscopic remission
Time frame: 24 months
The rate of endoscopic remission defined as Rutgeerts score ≤ 1 and SES-CD = 0 in early surgery and standard step-up therapy group respectively
3 secondary outcomes
QoL
Time frame: 24 months
Clinical remission
Time frame: 24 months
Drug consumption
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Background: PubMed 17206705Jess T, Riis L, Vind I, Winther KV, Borg S, Binder V, Langholz E, Thomsen OO, Munkholm P. Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark. Inflamm Bowel Dis. 2007 Apr;13(4):481-9. doi: 10.1002/ibd.20036.
- Background: PubMed 19832727Domenech E, Zabana Y, Garcia-Planella E, Lopez San Roman A, Nos P, Ginard D, Gordillo J, Martinez-Silva F, Beltran B, Manosa M, Cabre E, Gassull MA. Clinical outcome of newly diagnosed Crohn's disease: a comparative, retrospective study before and after infliximab availability. Aliment Pharmacol Ther. 2010 Jan 15;31(2):233-9. doi: 10.1111/j.1365-2036.2009.04170.x. Epub 2009 Oct 13.
- Background: PubMed 15647188Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294.
- Background: PubMed 24282358Golovics PA, Lakatos L, Nagy A, Pandur T, Szita I, Balogh M, Molnar C, Komaromi E, Lovasz BD, Mandel M, Veres G, Kiss LS, Vegh Z, Lakatos PL. Is early limited surgery associated with a more benign disease course in Crohn's disease? World J Gastroenterol. 2013 Nov 21;19(43):7701-10. doi: 10.3748/wjg.v19.i43.7701.
- Background: PubMed 18721465Eshuis EJ, Bemelman WA, van Bodegraven AA, Sprangers MA, Bossuyt PM, van Milligen de Wit AW, Crolla RM, Cahen DL, Oostenbrug LE, Sosef MN, Voorburg AM, Davids PH, van der Woude CJ, Lange J, Mallant RC, Boom MJ, Lieverse RJ, van der Zaag ES, Houben MH, Vecht J, Pierik RE, van Ditzhuijsen TJ, Prins HA, Marsman WA, Stockmann HB, Brink MA, Consten EC, van der Werf SD, Marinelli AW, Jansen JM, Gerhards MF, Bolwerk CJ, Stassen LP, Spanier BW, Bilgen EJ, van Berkel AM, Cense HA, van Heukelem HA, van de Laar A, Slot WB, Eijsbouts QA, van Ooteghem NA, van Wagensveld B, van den Brande JM, van Geloven AA, Bruin KF, Maring JK, Oldenburg B, van Hillegersberg R, de Jong DJ, Bleichrodt R, van der Peet DL, Dekkers PE, Goei TH, Stokkers PC. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial). BMC Surg. 2008 Aug 22;8:15. doi: 10.1186/1471-2482-8-15.
- Background: PubMed 2394349Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6.
- Background: PubMed 21646246Peyrin-Biroulet L, Cieza A, Sandborn WJ, Coenen M, Chowers Y, Hibi T, Kostanjsek N, Stucki G, Colombel JF; International Programme to Develop New Indexes for Crohn's Disease (IPNIC) group. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut. 2012 Feb;61(2):241-7. doi: 10.1136/gutjnl-2011-300049. Epub 2011 Jun 5.
- Background: PubMed 21122489Dignass A, Van Assche G, Lindsay JO, Lemann M, Soderholm J, Colombel JF, Danese S, D'Hoore A, Gassull M, Gomollon F, Hommes DW, Michetti P, O'Morain C, Oresland T, Windsor A, Stange EF, Travis SP; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis. 2010 Feb;4(1):28-62. doi: 10.1016/j.crohns.2009.12.002. Epub 2010 Jan 15. No abstract available.
- Background: PubMed 16432345Maartense S, Dunker MS, Slors JF, Cuesta MA, Pierik EG, Gouma DJ, Hommes DW, Sprangers MA, Bemelman WA. Laparoscopic-assisted versus open ileocolic resection for Crohn's disease: a randomized trial. Ann Surg. 2006 Feb;243(2):143-9; discussion 150-3. doi: 10.1097/01.sla.0000197318.37459.ec.
- Results publication: PubMed 17848181Aratari A, Papi C, Leandro G, Viscido A, Capurso L, Caprilli R. Early versus late surgery for ileo-caecal Crohn's disease. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1303-12. doi: 10.1111/j.1365-2036.2007.03515.x. Epub 2007 Sep 10.
- Individual participant dataSharing planned: Undecided
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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.
Ondrej Ryska, Dr, PhD principal investigator
Section of IBD surgery - Czech Surgical Society
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileocaecal resection in people with Crohn's Disease, run by Ondrej Ryska at 12 sites in Czechia.
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 13 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Czechia. 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 Ondrej Ryska, Dr, PhD (606254686 ext. 00420, ondrejryska@centrum.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic remission (time frame: 24 months). 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 NCT02716454, 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 28 Apr 2016.