CatheterizationDFGNCT03582540

Early Versus Delayed Double-guidewire Technique in Difficult Biliary Cannulation. (DFG)

A study testing Double-guidewire cannulation technique in people with Catheterization and Cholangiopancreatography, run by Société Française d'Endoscopie Digestive at 8 sites in France.

Completed

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

Official record

Search all trials

Trial summary

This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Catheterization, Cholangiopancreatography, Endoscopic Retrograde Cholangiography
What is being tested?: Double-guidewire cannulation technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 8 sitesFrance
Study dates: 2 Nov 2016to 30 Aug 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients 18 years old and more
Native papilla
Clinical indications of ERCP
Difficult biliary cannulation defined by unintentional guidewire insertion into the pancreatic duct before biliary cannulation is successful
Informed consent completed by the patient

Who cannot join

Contraindication to upper gastrointestinal endoscopy
ERCP with direct biliary cannulation success
ERCP with inability to cannulate the bile duct nor the pancreatic duct
Coagulation or hemostasis disorder (TP < 60%, TCA> 40 sec. et plaquettes < 60000/mm3).
Patient under active antiaggregant or anticoagulant medication other than aspirin
Endoscopic treatment of chronic pancreatitis

Show all 10Show fewer

Pregnancy or breastfeeding
ERCP performed by another operator than an investigator
Patient's voluntary withdrawal
Withdrawal decision by the investigator or sponsor

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

France8 sites

Clinique de Bercy
Charenton-le-Pont, 94220
Hôpital Dupuytren
Limoges, 87042
Hopital Saint Joseph
Marseille, 13008
Groupe Hospitalier Diaconesses - La Croix Saint-Simon
Paris, 75020
Hôpital Haut Lévêque
Pessac, 33600
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier de Bigorre
Tarbes, 65013
Centre Hospitalier de Vichy
Vichy, 03207

Other trials in France

About this study

Official title: Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.

Read the detailed description

This is a prospective study performed in 20 tertiary medical centers in France. We aim to recruit 150 patients from 2016 to 2020. Patients with a native papilla scheduled for ERCP (endoscopic retrograde cholangiopancreatography) are screened for the study. Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the double-guidewire technique immediately and the delayed arm uses the double-guidewire technique only if 10 more minutes of standard cannulation technique does not allow biliary cannulation. The primary outcome is the biliary cannulation rate success. Secondary outcomes are complications rate and performance of the technique in both arms. Follow-up is 30 days.

Conditions: Catheterization, Cholangiopancreatography, Endoscopic Retrograde Cholangiography, Biliary Cannulation, Difficult Biliary Cannulation, Double-guidewire Technique
Being tested: Double-guidewire cannulation technique

What participants receive

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

Double-guidewire cannulation techniqueProcedure or surgery
With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.

Study groups in NCT03582540
Study group	Role	What they receive
early double-guidewire technique (DGT)	Active comparator	First arm: early double-guidewire technique The early arm attempts biliary cannulation using the DGT immediately once the guidewire is inserted in the pancreatic duct in cases of difficult biliary cannulation. Receives: Procedure: Double-guidewire cannulation technique
delayed double-guidewire technique (DGT)	Active comparator	In the delayed arm, once the guidewire is inserted in the pancreatic duct, the operator continues to attempt biliary cannulation with conventional technique (contrast- or guidewire-assisted). DGT is used only if 10 more minutes of conventional cannulation technique does not allow biliary access. Receives: Procedure: Double-guidewire cannulation technique

What is being measured

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

Biliary cannulation success rate
The percentage of biliary cannulation success in both arms.
Measured: During the ERCP procedure

Secondary outcomes (3)

Immediate morbidity
Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period.
Measured: From the start, until 30 minutes after completion of ERCP
Delayed morbidity
Morbidities occurring more than 30 minutes and up to 1 month after ERCP completion. Special attention will be taken for bowel perforation, gastrointestinal bleeding and acute pancreatitis
Measured: 30 minutes after ERCP completion and up to 30 days
procedural time
The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation.
Measured: time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.

Timeline

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

2 Nov 201630 Aug 2019

First posted11 Jul 2018
Study start2 Nov 2016
Primary completion30 Jul 2019
Study completion30 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for CatheterizationStudies 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
Model description: Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the DGT immediately and the delayed arm uses the DGT only if 10 more minutes of conventional cannulation technique does not allow biliary cannulation.
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03582540
Sponsor's protocol ID: ID RCB: 2016-A01016-45
Acronym: DFG
Status last verified: Jun 2018
First submitted: 28 Jun 2018
Last updated: 23 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.
PubMed 15990812
Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. doi: 10.1016/s0016-5107(04)02463-0. No abstract available.
PubMed 15672074
Hisa T, Matsumoto R, Takamatsu M, Furutake M. Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement. World J Gastroenterol. 2011 Dec 28;17(48):5289-94. doi: 10.3748/wjg.v17.i48.5289.
PubMed 22219598
Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550.
PubMed 11577302
Artifon EL, Sakai P, Cunha JE, Halwan B, Ishioka S, Kumar A. Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation. Am J Gastroenterol. 2007 Oct;102(10):2147-53. doi: 10.1111/j.1572-0241.2007.01378.x. Epub 2007 Jun 20.
PubMed 17581267
Cennamo V, Fuccio L, Repici A, Fabbri C, Grilli D, Conio M, D'Imperio N, Bazzoli F. Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):473-9. doi: 10.1016/j.gie.2008.09.037.
PubMed 19231488
Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, Fabbri C, Bazzoli F. Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials. Endoscopy. 2010 May;42(5):381-8. doi: 10.1055/s-0029-1243992. Epub 2010 Mar 19.
PubMed 20306386
Parlak E, Cicek B, Disibeyaz S, Kuran S, Sahin B. Early decision for precut sphincterotomy: is it a risky preference? Dig Dis Sci. 2007 Mar;52(3):845-51. doi: 10.1007/s10620-006-9546-x.
PubMed 17273923
Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636. doi: 10.1016/s0016-5107(96)70038-x. No abstract available.
PubMed 8934189
Gotoh Y, Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Higashizawa T, Miyata T, Ido K, Sugano K. A new method for deep cannulation of the bile duct by straightening the pancreatic duct. Gastrointest Endosc. 2001 Jun;53(7):820-2. doi: 10.1067/mge.2001.113387. No abstract available.
PubMed 11375604
Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, Roston AD, Slivka A, Lichtenstein DR, Ruymann FW, Van Dam J, Hughes M, Carr-Locke DL. Risk factors for complications after performance of ERCP. Gastrointest Endosc. 2002 Nov;56(5):652-6. doi: 10.1067/mge.2002.129086.
PubMed 12397271
Caletti GC, Vandelli A, Bolondi L, Fontana G, Labo G. Endoscopic retrograde cholangiography (ERC) through artificial endoscopic choledocho-duodenal fistula. Endoscopy. 1978 Aug;10(3):203-6. doi: 10.1055/s-0028-1098295.
PubMed 699889
Siegel JH. Precut papillotomy: a method to improve success of ERCP and papillotomy. Endoscopy. 1980 May;12(3):130-3. doi: 10.1055/s-2007-1021728.
PubMed 7379762
Osnes M, Kahrs T. Endoscopic choledochoduodenostomy for choledocholithiasis through choledochoduodenal fistula. Endoscopy. 1977 Aug;9(3):162-5. doi: 10.1055/s-0028-1098510.
PubMed 913369
Dumonceau JM, Deviere J, Cremer M. A new method of achieving deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography. Endoscopy. 1998 Sep;30(7):S80. doi: 10.1055/s-2007-1001379. No abstract available.
PubMed 9826155

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

Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
RecruitingObservational study
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
Pulmonary Hypertension, Pulmonary Arterial Hypertension

All Catheterization trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.
ClinicalTrials.gov ID: NCT03582540
Acronym / sponsor ID: DFG / ID RCB: 2016-A01016-45
Conditions: Catheterization, Cholangiopancreatography, Endoscopic Retrograde Cholangiography, Biliary Cannulation, Difficult Biliary Cannulation, Double-guidewire Technique
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Société Française d'Endoscopie DigestiveUniversity, hospital or other
Study start: 2 Nov 2016 (actual)
Primary completion: 30 Jul 2019 (actual)
Study completion: 30 Aug 2019 (actual)
First posted: 11 Jul 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the DGT immediately and the delayed arm uses the DGT only if 10 more minutes of conventional cannulation technique does not allow biliary cannulation.

Arm	Type	Receives
early double-guidewire technique (DGT)	Active comparator	Procedure: Double-guidewire cannulation techniqueFirst arm: early double-guidewire technique The early arm attempts biliary cannulation using the DGT immediately once the guidewire is inserted in the pancreatic duct in cases of difficult biliary cannulation.
delayed double-guidewire technique (DGT)	Active comparator	Procedure: Double-guidewire cannulation techniqueIn the delayed arm, once the guidewire is inserted in the pancreatic duct, the operator continues to attempt biliary cannulation with conventional technique (contrast- or guidewire-assisted). DGT is used only if 10 more minutes of conventional cannulation technique does not allow biliary access.

Who may qualify

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

Key inclusion criteria (5 listed)

Patients 18 years old and more
Native papilla
Clinical indications of ERCP
Difficult biliary cannulation defined by unintentional guidewire insertion into the pancreatic duct before biliary cannulation is successful
Informed consent completed by the patient

Key exclusion criteria (10 listed)

Contraindication to upper gastrointestinal endoscopy
ERCP with direct biliary cannulation success
ERCP with inability to cannulate the bile duct nor the pancreatic duct
Coagulation or hemostasis disorder (TP < 60%, TCA> 40 sec. et plaquettes < 60000/mm3).
Patient under active antiaggregant or anticoagulant medication other than aspirin

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
Double-guidewire cannulation techniqueWith the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.	Procedure or surgery	delayed double-guidewire technique (DGT), early double-guidewire technique (DGT)

Primary outcome

Biliary cannulation success rate
Time frame: During the ERCP procedure
The percentage of biliary cannulation success in both arms.

3 secondary outcomes

Immediate morbidity
Time frame: From the start, until 30 minutes after completion of ERCP
Delayed morbidity
Time frame: 30 minutes after ERCP completion and up to 30 days
procedural time
Time frame: time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.

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 23 Sep 2019.
Results publication: PubMed 15990812Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.
Results publication: PubMed 15672074Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. doi: 10.1016/s0016-5107(04)02463-0. No abstract available.
Results publication: PubMed 22219598Hisa T, Matsumoto R, Takamatsu M, Furutake M. Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement. World J Gastroenterol. 2011 Dec 28;17(48):5289-94. doi: 10.3748/wjg.v17.i48.5289.
Results publication: PubMed 11577302Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550.
Results publication: PubMed 17581267Artifon EL, Sakai P, Cunha JE, Halwan B, Ishioka S, Kumar A. Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation. Am J Gastroenterol. 2007 Oct;102(10):2147-53. doi: 10.1111/j.1572-0241.2007.01378.x. Epub 2007 Jun 20.
Results publication: PubMed 19231488Cennamo V, Fuccio L, Repici A, Fabbri C, Grilli D, Conio M, D'Imperio N, Bazzoli F. Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):473-9. doi: 10.1016/j.gie.2008.09.037.
Results publication: PubMed 20306386Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, Fabbri C, Bazzoli F. Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials. Endoscopy. 2010 May;42(5):381-8. doi: 10.1055/s-0029-1243992. Epub 2010 Mar 19.
Results publication: PubMed 17273923Parlak E, Cicek B, Disibeyaz S, Kuran S, Sahin B. Early decision for precut sphincterotomy: is it a risky preference? Dig Dis Sci. 2007 Mar;52(3):845-51. doi: 10.1007/s10620-006-9546-x.
Results publication: PubMed 8934189Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636. doi: 10.1016/s0016-5107(96)70038-x. No abstract available.
Results publication: PubMed 11375604Gotoh Y, Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Higashizawa T, Miyata T, Ido K, Sugano K. A new method for deep cannulation of the bile duct by straightening the pancreatic duct. Gastrointest Endosc. 2001 Jun;53(7):820-2. doi: 10.1067/mge.2001.113387. No abstract available.
Results publication: PubMed 12397271Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, Roston AD, Slivka A, Lichtenstein DR, Ruymann FW, Van Dam J, Hughes M, Carr-Locke DL. Risk factors for complications after performance of ERCP. Gastrointest Endosc. 2002 Nov;56(5):652-6. doi: 10.1067/mge.2002.129086.
Results publication: PubMed 699889Caletti GC, Vandelli A, Bolondi L, Fontana G, Labo G. Endoscopic retrograde cholangiography (ERC) through artificial endoscopic choledocho-duodenal fistula. Endoscopy. 1978 Aug;10(3):203-6. doi: 10.1055/s-0028-1098295.
Individual participant dataSharing planned: No

Related trials for Catheterization

Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
RecruitingObservational study
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
Pulmonary Hypertension, Pulmonary Arterial Hypertension

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.

ARTHUR LAQUIERE, MD principal investigator

Société Française d'Endoscopie Digestive

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

Questions about this trial

What is this clinical trial studying?

A study testing Double-guidewire cannulation technique in people with Catheterization and Cholangiopancreatography, run by Société Française d'Endoscopie Digestive at 8 sites in France.

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: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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?

Biliary cannulation success rate (time frame: During the ERCP procedure). 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 NCT03582540, which also lists 24 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 23 Sep 2019.