Acute CholecystitisNCT04543578
Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.
An observational study of Acute Cholecystitis, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Acute cholecystitis is a complex disease and its management is sometimes controversial. Two main factors contribute to its complexity: the patient's surgical risk and the possibility of concomitant choledocholithiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attended in the emergency department of CHN and diagnosed with acute cholecystitis.
Who may be able to join
- Patients aged 18 or older who agree to participate (an informed consent signature is required)
- Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
Who cannot join
- Patients under 18 years or patients who refuse to participate in the study
- Patients diagnosed with acute cholangitis during admission for other causes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Federico Bolado Concejo, MD, PhD, 848422025, fboladoc@cfnavarra.es
Ruth García Rey, MSc, 848422163, ruth.garcia.rey@navarra.es
About this study
Official title: Evaluation of the Applicability and Effectiveness of a Protocol for the Multidisciplinary Management of Acute Cholecystitis
Acute cholecystitis is a complex disease and its management is sometimes controversial. Two main factors contribute to its complexity: the patient's surgical risk and the possibility of concomitant choledocholithiasis. The design of a multidisciplinary protocol between the services of Gastroenterology and Surgery aims to harmonize its management and to adapt it to the most recent guidelines. As it concerns more than one department, it is crucial to analyze its compliance and effectiveness.
Read the detailed description
Adult patients attending the emergency department and diagnosed with acute cholecystitis will be asked to participate. Those considered not suitable for surgery will be admitted in a medical department and assigned to conservative treatment or cholecystostomy, according to their acute cholecystitis severity. In patients suitable for surgery, risk of concomitant choledocholithiasis will be assessed and patients will be assigned to low risk or intermediate-high risk. The latter will be admitted in a medical department, and choledocholithiasis will be ruled out and treated if present. The former will be offered cholecystectomy or cholecystostomy according to their surgical risk and acute cholecystitis severity. A flowchart with extended information is attached.
PRIMARY OBJECTIVES
- To harmonize the management of acute cholecystitis with a multidisciplinary protocol based on the most recent guidelines.
SECONDARY OBJECTIVES
- To analyze the compliance with this protocol.
- To evaluate the validity of the criteria used in the decision-making process.
- To assess the morbidity and mortality of different groups of patients according to the selected treatment, severity of cholecystitis and baseline characteristics of the patient.
- To estimate the resource use in each group of patients.
- To compare current data with a previous period.
- To adapt and modify the protocol according the study results. INCLUSION CRITERIA
- Patients aged 18 or older who agree to participate (an informed consent signature is required)
- Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
EXCLUSION CRITERIA
- Patients under 18 years or patients who refuse to participate in the study
- Patients diagnosed with acute cholangitis during admission for other causes.
- Conditions
- Acute Cholecystitis
- Keywords
- Acute cholecystitis, EUS-guided cholecystostomy, Percutaneous cholecystostomy, Laparoscopic cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients unfit for Surgery with mild-moderate acute cholecyst | Conservative treatment (antibiotics, etc). EUS-guided gallbladder drainage will be considered in recurrent acute cholecystitis and in patients with no improvement in 48-72h after admission. | |
| Patients unfit for Surgery with severe acute cholecystitis | Percutaneous cholecystostomy or Endoscopic Ultrasound (EUS)-guided cholecystostomy (the latter is not 24/7 available). Palliative care may also be considered in patients with very serious conditions and low life expectancy. | |
| Patients suitable for Surgery with high and intermediate risk | Admission in Gastroenterology Department. antibiotic treatment. Close follow-up of posible AC complications. Once choledocholithiasis is solved or ruled our, the patient will be considered for same-admission cholecystectomy or programmed cholecystectomy. * High risk: Endoscopic Retrograde Cholangiopancreatography (ERCP) will be performed. * Intermediate risk: EUS or Magnetic Resonance Cholangiopancreatography prior to consider ERCP. | |
| Patients suitable for Surgery with low risk | Admission in Surgery Department. According to the AC severity: * Mild-moderate AC: check de ASA/Charlson comorbidity index. * ASA I-II/Charlson <6: laparoscopic cholecystectomy * ASA > =III/Charlson >=6: close follow-up 24-48h. Consider laparoscopic cholecystostomy (if no improvement is achieved) * Severe AC: consider Intensive Care Unit admission. Percutaneous cholecystectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclusion rate
Rate of patients with AC diagnosis registered in the study
Measured: During inclusion period
Protocol compliance
Rate of patients with complete protocol compliance
Measured: During inclusion period
Morbidity in the different subtypes of patients
length of hospital stay, need for unplanned readmissions, recurrent cholecystitis
Measured: three months after hospital discharge
Mortality in the different subtypes of patients
90-day disease-specific mortality
Measured: three months after hospital discharge
Secondary outcomes (3)
Protocol compliance failure
Identify causes of protocol compliance failure
Measured: every 3 months throughout study completion (up to 1 year)
Evaluate the technical success
Evaluate clinical success and adverse events of the different treatments.
Measured: During inclusion period (up to 1 year)
Evaluate the accuracy in the diagnosis
Evaluate the accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) and EUS in the diagnosis of concomitant choledocholithiasis
Measured: three months after hospital discharge or after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jul 2020
- Primary completionJul 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Bolado Concejo, MD, PhD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543578
- Sponsor's protocol ID
- DIGESTIVO CHN-VBP
- Status last verified
- Dec 2020
- First submitted
- 2 Sep 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
PubMed 29032636Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016.
PubMed 27307785Chisholm PR, Patel AH, Law RJ, Schulman AR, Bedi AO, Kwon RS, Wamsteker EJ, Anderson MA, Elta GH, Govani SM, Prabhu A. Preoperative predictors of choledocholithiasis in patients presenting with acute calculous cholecystitis. Gastrointest Endosc. 2019 May;89(5):977-983.e2. doi: 10.1016/j.gie.2018.11.017. Epub 2018 Nov 19.
PubMed 30465770ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
PubMed 20105473ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
PubMed 30979521Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.
PubMed 30943551Luk SW, Irani S, Krishnamoorthi R, Wong Lau JY, Wai Ng EK, Teoh AY. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-732. doi: 10.1055/a-0929-6603. Epub 2019 Jun 25.
PubMed 31238375
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Applicability and Effectiveness of a Protocol for the Multidisciplinary Management of Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT04543578
- Acronym / sponsor ID
- DIGESTIVO CHN-VBP
- Conditions
- Acute Cholecystitis
- Keywords
- Acute cholecystitis, EUS-guided cholecystostomy, Percutaneous cholecystostomy, Laparoscopic cholecystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Sep 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.
Acute cholecystitis is a complex disease and its management is sometimes controversial. Two main factors contribute to its complexity: the patient's surgical risk and the possibility of concomitant choledocholithiasis. The design of a multidisciplinary protocol between the services of Gastroenterology and Surgery aims to harmonize its management and to adapt it to the most recent guidelines. As it concerns more than one department, it is crucial to analyze its compliance and effectiveness.
Detailed description
Adult patients attending the emergency department and diagnosed with acute cholecystitis will be asked to participate. Those considered not suitable for surgery will be admitted in a medical department and assigned to conservative treatment or cholecystostomy, according to their acute cholecystitis severity. In patients suitable for surgery, risk of concomitant choledocholithiasis will be assessed and patients will be assigned to low risk or intermediate-high risk. The latter will be admitted in a medical department, and choledocholithiasis will be ruled out and treated if present. The former will be offered cholecystectomy or cholecystostomy according to their surgical risk and acute cholecystitis severity. A flowchart with extended information is attached.
PRIMARY OBJECTIVES
- To harmonize the management of acute cholecystitis with a multidisciplinary protocol based on the most recent guidelines.
SECONDARY OBJECTIVES
- To analyze the compliance with this protocol.
- To evaluate the validity of the criteria used in the decision-making process.
- To assess the morbidity and mortality of different groups of patients according to the selected treatment, severity of cholecystitis and baseline characteristics of the patient.
- To estimate the resource use in each group of patients.
- To compare current data with a previous period.
- To adapt and modify the protocol according the study results. INCLUSION CRITERIA
- Patients aged 18 or older who agree to participate (an informed consent signature is required)
- Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
EXCLUSION CRITERIA
- Patients under 18 years or patients who refuse to participate in the study
- Patients diagnosed with acute cholangitis during admission for other causes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients unfit for Surgery with mild-moderate acute cholecyst | – | –Conservative treatment (antibiotics, etc). EUS-guided gallbladder drainage will be considered in recurrent acute cholecystitis and in patients with no improvement in 48-72h after admission. |
| Patients unfit for Surgery with severe acute cholecystitis | – | –Percutaneous cholecystostomy or Endoscopic Ultrasound (EUS)-guided cholecystostomy (the latter is not 24/7 available). Palliative care may also be considered in patients with very serious conditions and low life expectancy. |
| Patients suitable for Surgery with high and intermediate risk | – | –Admission in Gastroenterology Department. antibiotic treatment. Close follow-up of posible AC complications. Once choledocholithiasis is solved or ruled our, the patient will be considered for same-admission cholecystectomy or programmed cholecystectomy. * High risk: Endoscopic Retrograde Cholangiopancreatography (ERCP) will be performed. * Intermediate risk: EUS or Magnetic Resonance Cholangiopancreatography prior to consider ERCP. |
| Patients suitable for Surgery with low risk | – | –Admission in Surgery Department. According to the AC severity: * Mild-moderate AC: check de ASA/Charlson comorbidity index. * ASA I-II/Charlson <6: laparoscopic cholecystectomy * ASA > =III/Charlson >=6: close follow-up 24-48h. Consider laparoscopic cholecystostomy (if no improvement is achieved) * Severe AC: consider Intensive Care Unit admission. Percutaneous cholecystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attended in the emergency department of CHN and diagnosed with acute cholecystitis.
Key inclusion criteria (2 listed)
- Patients aged 18 or older who agree to participate (an informed consent signature is required)
- Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
Key exclusion criteria (2 listed)
- Patients under 18 years or patients who refuse to participate in the study
- Patients diagnosed with acute cholangitis during admission for other causes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inclusion rate
Time frame: During inclusion period
Rate of patients with AC diagnosis registered in the study
Protocol compliance
Time frame: During inclusion period
Rate of patients with complete protocol compliance
Morbidity in the different subtypes of patients
Time frame: three months after hospital discharge
length of hospital stay, need for unplanned readmissions, recurrent cholecystitis
Mortality in the different subtypes of patients
Time frame: three months after hospital discharge
90-day disease-specific mortality
3 secondary outcomes
Protocol compliance failure
Time frame: every 3 months throughout study completion (up to 1 year)
Evaluate the technical success
Time frame: During inclusion period (up to 1 year)
Evaluate the accuracy in the diagnosis
Time frame: three months after hospital discharge or after ERCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Background: PubMed 29032636Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
- Background: PubMed 27307785Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016.
- Background: PubMed 30465770Chisholm PR, Patel AH, Law RJ, Schulman AR, Bedi AO, Kwon RS, Wamsteker EJ, Anderson MA, Elta GH, Govani SM, Prabhu A. Preoperative predictors of choledocholithiasis in patients presenting with acute calculous cholecystitis. Gastrointest Endosc. 2019 May;89(5):977-983.e2. doi: 10.1016/j.gie.2018.11.017. Epub 2018 Nov 19.
- Background: PubMed 20105473ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
- Background: PubMed 30979521ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
- Background: PubMed 30943551Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.
- Background: PubMed 31238375Luk SW, Irani S, Krishnamoorthi R, Wong Lau JY, Wai Ng EK, Teoh AY. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-732. doi: 10.1055/a-0929-6603. Epub 2019 Jun 25.
- 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.
Federico Bolado Concejo, MD, PhD principal investigator
Complejo Hospitalario de Navarra
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 Acute Cholecystitis, run by Fundacion Miguel Servet at 1 site in Spain.
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 2 inclusion and 2 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 14 Dec 2020. 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 Spain. 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 Federico Bolado Concejo, MD, PhD (0034848422025, fboladoc@cfnavarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion rate (time frame: During inclusion period). The study lists 4 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 NCT04543578, which also lists 7 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 14 Dec 2020.