PancreatitisNCT04492124
Influence of Vater's Ampulla Morphology on ERCP
An observational study of Pancreatitis, run by University of Minho at 1 site in Portugal.
Trial summary
Determine the influence of the papilla's morphology on the various outcomes of endoscopic retrograde cholangiopancreatography (ERCP), namely on the success of biliary cannulation, on complications, and on the need to use rescue cannulation techniques; Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- How many people
- 400 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2020to 1 Jun 2022
- How long will I take part?
- 30 Days
- 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
- Adult, Older adult
Study population: All individuals referred for CPRE in the Digestive Endoscopy Unit of the Santa Luzia Hospital, Unidade Local de Saúde do Alto Minho, will be invited to participate in the study, in the period between June 1, 2020 to June 1, 2022.
Who may be able to join
- ERCP with indication for biliary access
- Naïve papilla
Who cannot join
- Patients unable to understand the informed consent
- Patients with surgically altered anatomy
- Patients with tumors of the papilla
- Previous sphincterotomy
- Spontaneous papillary fistula
- Papilla not visualized
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Santa Luzia Hospital, Unidade Local de Saúde do Alto Minho
Viana do Castelo, 4904-858
Luís Lopes, +351938241974, luis.m.lopes@me.com
João Fernandes, +351960315790, jotillfernandes@hotmail.com
About this study
Official title: Influence of Vater's Ampulla Morphology on Biliary Cannulation Rate, Complications and Advanced Biliary Cannulation Techniques
Determine the influence of the papilla's morphology on the various outcomes of endoscopic retrograde cholangiopancreatography (ERCP), namely on the success of biliary cannulation, on complications, and on the need to use rescue cannulation techniques;
Read the detailed description
- Background ERCP is an advanced procedure which is widely used in the diagnosis and treatment of a variety of benign and malignant pancreatobiliary disorders1,2,3,4,5. Selective cannulation of the common bile duct (CBD) is the most important and challenging step in a biliary endoscopic retrograde cholangiopancreatography6,7. However, in the first ERCP, even in experienced hands, biliary cannulation may fail in up to 15 % - 35 % of cases when using standard methods alone8. Since the first description of the "Vater's papilla" by Abraham Vater in 17209, the variability in papillary morphology has been widely recognized10. The use of high quality digital images has led to a clear need and desire to create an endoscopic classification based on the papilla's morphology. During the last decade, several authors have proposed different classifications in order to predict the success of cannulation, complications and the need for more advanced cannulation techniques11,12,13,14,15. However, all the proposed classifications, with the exception of one, fail because they have not been submitted to a validation process. The only validated one is the proposed by Haraldsson13, which still has the drawback of not incorporating some of the papillary morphologies. Given the need, our research group created a new classification (entitled "Viana Classification") that not only incorporates more morphologies but was also validated in due course. Hence, the next step is to explore the potential implications of papillary morphology on the success of biliary cannulation, complications resulting from ERCP and the need to use rescue techniques (fistulotomy and double-guidewire cannulation) in the event of failure of the standard cannulation.
- Financial resources All participants included in this study will perform ERCP, laboratory tests and other complementary diagnostic tests after a duly justified medical prescription (the exact same exams that the patient would do if there wasn't this study). Therefore, there are no additional costs or consumption of hospital resources.
- Ethical considerations In this study, participants will be included after informed consent. Anonymity and confidentiality will be safeguarded by assigning an individual numeric code. It will also be explained the possibility of withdrawing from the study at any time, with the guarantee of the total elimination of data. All researchers involved in the study will adhere to the Rules of Ethical Conduct and Best Practices in order to comply with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practice.
- Statistical analysis Qualitative variables will be summarized using absolute and relative frequencies, and quantitative variables will be summarized using the mean and standard deviation or the median and interquartile range, depending on their distribution profiles. The normality of the quantitative variables will be assessed using the histogram distribution. Relations between categorical variables will be assessed using a chi-square test and Fisher´s exact test. Differences between two or more groups of independent non-normally distributed quantitative variables will be evaluated using a Kruskal-Wallis test. To explain the risk of pancreatitis, a binomial logistic regression model with multiple predictors will be performed. The null hypothesis will be rejected when the test statistics p-values are less than <0.05. Statistical analysis, sample size calculation and graphics will be performed using Stata software (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, StataCorp LP)
- Expected results
The results from this study will contribute to a better understanding of the influence of papillary morphology on cannulation difficulty. In the event of demonstrating that some morphologies imply greater difficulty in cannulation, strategies may be created, such as the use of ab initio rescue techniques, in order to improve the results of ERCP, namely the cannulation rate.
- Conditions
- Pancreatitis
- Keywords
- Vater's ampulla, Major Papilla, ERCP, Biliary cannulation, Precut
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the morphology of the Vater's Ampulla and biliary cannulation difficulty
Correlation between the morphology of the Papilla de Vater, defined by the Viana classification, and the difficulty of cannulation between experts and other endoscopists (initiates and non-expert specialists)
Measured: 1 day
Secondary outcomes (1)
Correlation between the morphology of the Vater's Ampulla, and complications, and need/success of advanced cannulation techniques
Correlation between the morphology of the Vater's Ampulla, defined by the Viana classification, and complications, and need/success of advanced cannulation techniques (fistulotomy and double-guidewire cannulation)
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Minho
- Responsible party
- Principal investigator, Luis Lopes, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492124
- Sponsor's protocol ID
- 30/2020
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canena J, Liberato M, Coutinho AP, Marques I, Romao C, Veiga PM, Neves BC. Predictive value of cholangioscopy after endoscopic management of early postcholecystectomy bile duct strictures with an increasing number of plastic stents: a prospective study (with videos). Gastrointest Endosc. 2014 Feb;79(2):279-88. doi: 10.1016/j.gie.2013.07.022. Epub 2013 Sep 5.
PubMed 24012251Canena J, Coimbra J, Carvalho D, Rodrigues C, Silva M, Costa M, Horta D, Mateus Dias A, Seves I, Ramos G, Ricardo L, Coutinho AP, Romao C, Veiga PM. Endoscopic bilio-duodenal bypass: outcomes of primary and revision efficacy of combined metallic stents in malignant duodenal and biliary obstructions. Dig Dis Sci. 2014 Nov;59(11):2779-89. doi: 10.1007/s10620-014-3199-y. Epub 2014 May 13.
PubMed 24821464Canena J, Liberato M, Meireles L, Marques I, Romao C, Coutinho AP, Neves BC, Veiga PM. A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos). Gastrointest Endosc. 2015 Jul;82(1):70-8. doi: 10.1016/j.gie.2014.11.038. Epub 2015 Mar 11.
PubMed 25771064Canena J. Once upon a Time a Guideline Was Used for the Evaluation of Suspected Choledocholithiasis: A Fairy Tale or a Nightmare? GE Port J Gastroenterol. 2018 Jan;25(1):6-9. doi: 10.1159/000481688. Epub 2017 Nov 8. No abstract available.
PubMed 29457044Canena J, Lopes L, Fernandes J, Alexandrino G, Lourenco L, Libanio D, Horta D, Giestas S, Reis J. Outcomes of Single-Operator Cholangioscopy-Guided Lithotripsy in Patients with Difficult Biliary and Pancreatic Stones. GE Port J Gastroenterol. 2019 Mar;26(2):105-113. doi: 10.1159/000488508. Epub 2018 May 16.
PubMed 30976615Lopes L, Dinis-Ribeiro M, Rolanda C. Safety and efficacy of precut needle-knife fistulotomy. Scand J Gastroenterol. 2014 Jun;49(6):759-65. doi: 10.3109/00365521.2014.898085. Epub 2014 Mar 18.
PubMed 24641260Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
PubMed 27299638Testoni PA, Testoni S, Giussani A. Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis. Dig Liver Dis. 2011 Aug;43(8):596-603. doi: 10.1016/j.dld.2011.01.019. Epub 2011 Mar 4.
PubMed 21377432Lerch MM, Domschke W. Abraham Vater of the ampulla (papilla) of Vater. Gastroenterology. 2000 Feb;118(2):379. doi: 10.1016/s0016-5085(00)70243-5. No abstract available.
PubMed 10691372Vater A. Dissertatio anatomica quo novum bilis dicetilicum circa orifucum ductus choledochi ut et valvulosam colli vesicæ felleæ constructionem ad disceptandum proponit. Wittenberg 1720
Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N. Effect of precut sphincterotomy on biliary cannulation based on the characteristics of the major duodenal papilla. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1113-8. doi: 10.1016/j.cgh.2007.05.014. Epub 2007 Aug 6.
PubMed 17689295Lee TH, Bang BW, Park SH, Jeong S, Lee DH, Kim SJ. Precut fistulotomy for difficult biliary cannulation: is it a risky preference in relation to the experience of an endoscopist? Dig Dis Sci. 2011 Jun;56(6):1896-903. doi: 10.1007/s10620-010-1483-z. Epub 2010 Nov 17.
PubMed 21082346Haraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17.
PubMed 28588881Haraldsson E, Kylanpaa L, Gronroos J, Saarela A, Toth E, Qvigstad G, Hult M, Lindstrom O, Laine S, Karjula H, Hauge T, Sadik R, Arnelo U. Macroscopic appearance of the major duodenal papilla influences bile duct cannulation: a prospective multicenter study by the Scandinavian Association for Digestive Endoscopy Study Group for ERCP. Gastrointest Endosc. 2019 Dec;90(6):957-963. doi: 10.1016/j.gie.2019.07.014. Epub 2019 Jul 18.
PubMed 31326385Watanabe M, Okuwaki K, Kida M, Imaizumi H, Yamauchi H, Kaneko T, Iwai T, Hasegawa R, Miyata E, Masutani H, Tadehara M, Adachi K, Koizumi W. Transpapillary Biliary Cannulation is Difficult in Cases with Large Oral Protrusion of the Duodenal Papilla. Dig Dis Sci. 2019 Aug;64(8):2291-2299. doi: 10.1007/s10620-019-05510-z. Epub 2019 Feb 12.
PubMed 30746630
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vater's Ampulla Morphology on Biliary Cannulation Rate, Complications and Advanced Biliary Cannulation Techniques
- ClinicalTrials.gov ID
- NCT04492124
- Acronym / sponsor ID
- 30/2020
- Conditions
- Pancreatitis
- Keywords
- Vater's ampulla, Major Papilla, ERCP, Biliary cannulation, Precut
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Minho
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 30 Jul 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.
Determine the influence of the papilla's morphology on the various outcomes of endoscopic retrograde cholangiopancreatography (ERCP), namely on the success of biliary cannulation, on complications, and on the need to use rescue cannulation techniques;
Detailed description
- Background ERCP is an advanced procedure which is widely used in the diagnosis and treatment of a variety of benign and malignant pancreatobiliary disorders1,2,3,4,5. Selective cannulation of the common bile duct (CBD) is the most important and challenging step in a biliary endoscopic retrograde cholangiopancreatography6,7. However, in the first ERCP, even in experienced hands, biliary cannulation may fail in up to 15 % - 35 % of cases when using standard methods alone8. Since the first description of the "Vater's papilla" by Abraham Vater in 17209, the variability in papillary morphology has been widely recognized10. The use of high quality digital images has led to a clear need and desire to create an endoscopic classification based on the papilla's morphology. During the last decade, several authors have proposed different classifications in order to predict the success of cannulation, complications and the need for more advanced cannulation techniques11,12,13,14,15. However, all the proposed classifications, with the exception of one, fail because they have not been submitted to a validation process. The only validated one is the proposed by Haraldsson13, which still has the drawback of not incorporating some of the papillary morphologies. Given the need, our research group created a new classification (entitled "Viana Classification") that not only incorporates more morphologies but was also validated in due course. Hence, the next step is to explore the potential implications of papillary morphology on the success of biliary cannulation, complications resulting from ERCP and the need to use rescue techniques (fistulotomy and double-guidewire cannulation) in the event of failure of the standard cannulation.
- Financial resources All participants included in this study will perform ERCP, laboratory tests and other complementary diagnostic tests after a duly justified medical prescription (the exact same exams that the patient would do if there wasn't this study). Therefore, there are no additional costs or consumption of hospital resources.
- Ethical considerations In this study, participants will be included after informed consent. Anonymity and confidentiality will be safeguarded by assigning an individual numeric code. It will also be explained the possibility of withdrawing from the study at any time, with the guarantee of the total elimination of data. All researchers involved in the study will adhere to the Rules of Ethical Conduct and Best Practices in order to comply with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practice.
- Statistical analysis Qualitative variables will be summarized using absolute and relative frequencies, and quantitative variables will be summarized using the mean and standard deviation or the median and interquartile range, depending on their distribution profiles. The normality of the quantitative variables will be assessed using the histogram distribution. Relations between categorical variables will be assessed using a chi-square test and Fisher´s exact test. Differences between two or more groups of independent non-normally distributed quantitative variables will be evaluated using a Kruskal-Wallis test. To explain the risk of pancreatitis, a binomial logistic regression model with multiple predictors will be performed. The null hypothesis will be rejected when the test statistics p-values are less than <0.05. Statistical analysis, sample size calculation and graphics will be performed using Stata software (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, StataCorp LP)
- Expected results
The results from this study will contribute to a better understanding of the influence of papillary morphology on cannulation difficulty. In the event of demonstrating that some morphologies imply greater difficulty in cannulation, strategies may be created, such as the use of ab initio rescue techniques, in order to improve the results of ERCP, namely the cannulation rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All individuals referred for CPRE in the Digestive Endoscopy Unit of the Santa Luzia Hospital, Unidade Local de Saúde do Alto Minho, will be invited to participate in the study, in the period between June 1, 2020 to June 1, 2022.
Key inclusion criteria (2 listed)
- ERCP with indication for biliary access
- Naïve papilla
Key exclusion criteria (6 listed)
- Patients unable to understand the informed consent
- Patients with surgically altered anatomy
- Patients with tumors of the papilla
- Previous sphincterotomy
- Spontaneous papillary fistula
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
Correlation between the morphology of the Vater's Ampulla and biliary cannulation difficulty
Time frame: 1 day
Correlation between the morphology of the Papilla de Vater, defined by the Viana classification, and the difficulty of cannulation between experts and other endoscopists (initiates and non-expert specialists)
1 secondary outcome
Correlation between the morphology of the Vater's Ampulla, and complications, and need/success of advanced cannulation techniques
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 24012251Canena J, Liberato M, Coutinho AP, Marques I, Romao C, Veiga PM, Neves BC. Predictive value of cholangioscopy after endoscopic management of early postcholecystectomy bile duct strictures with an increasing number of plastic stents: a prospective study (with videos). Gastrointest Endosc. 2014 Feb;79(2):279-88. doi: 10.1016/j.gie.2013.07.022. Epub 2013 Sep 5.
- Background: PubMed 24821464Canena J, Coimbra J, Carvalho D, Rodrigues C, Silva M, Costa M, Horta D, Mateus Dias A, Seves I, Ramos G, Ricardo L, Coutinho AP, Romao C, Veiga PM. Endoscopic bilio-duodenal bypass: outcomes of primary and revision efficacy of combined metallic stents in malignant duodenal and biliary obstructions. Dig Dis Sci. 2014 Nov;59(11):2779-89. doi: 10.1007/s10620-014-3199-y. Epub 2014 May 13.
- Background: PubMed 25771064Canena J, Liberato M, Meireles L, Marques I, Romao C, Coutinho AP, Neves BC, Veiga PM. A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos). Gastrointest Endosc. 2015 Jul;82(1):70-8. doi: 10.1016/j.gie.2014.11.038. Epub 2015 Mar 11.
- Background: PubMed 29457044Canena J. Once upon a Time a Guideline Was Used for the Evaluation of Suspected Choledocholithiasis: A Fairy Tale or a Nightmare? GE Port J Gastroenterol. 2018 Jan;25(1):6-9. doi: 10.1159/000481688. Epub 2017 Nov 8. No abstract available.
- Background: PubMed 30976615Canena J, Lopes L, Fernandes J, Alexandrino G, Lourenco L, Libanio D, Horta D, Giestas S, Reis J. Outcomes of Single-Operator Cholangioscopy-Guided Lithotripsy in Patients with Difficult Biliary and Pancreatic Stones. GE Port J Gastroenterol. 2019 Mar;26(2):105-113. doi: 10.1159/000488508. Epub 2018 May 16.
- Background: PubMed 24641260Lopes L, Dinis-Ribeiro M, Rolanda C. Safety and efficacy of precut needle-knife fistulotomy. Scand J Gastroenterol. 2014 Jun;49(6):759-65. doi: 10.3109/00365521.2014.898085. Epub 2014 Mar 18.
- Background: PubMed 27299638Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
- Background: PubMed 21377432Testoni PA, Testoni S, Giussani A. Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis. Dig Liver Dis. 2011 Aug;43(8):596-603. doi: 10.1016/j.dld.2011.01.019. Epub 2011 Mar 4.
- Background: PubMed 10691372Lerch MM, Domschke W. Abraham Vater of the ampulla (papilla) of Vater. Gastroenterology. 2000 Feb;118(2):379. doi: 10.1016/s0016-5085(00)70243-5. No abstract available.
- BackgroundVater A. Dissertatio anatomica quo novum bilis dicetilicum circa orifucum ductus choledochi ut et valvulosam colli vesicæ felleæ constructionem ad disceptandum proponit. Wittenberg 1720
- Background: PubMed 17689295Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N. Effect of precut sphincterotomy on biliary cannulation based on the characteristics of the major duodenal papilla. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1113-8. doi: 10.1016/j.cgh.2007.05.014. Epub 2007 Aug 6.
- Background: PubMed 21082346Lee TH, Bang BW, Park SH, Jeong S, Lee DH, Kim SJ. Precut fistulotomy for difficult biliary cannulation: is it a risky preference in relation to the experience of an endoscopist? Dig Dis Sci. 2011 Jun;56(6):1896-903. doi: 10.1007/s10620-010-1483-z. Epub 2010 Nov 17.
- Individual participant dataSharing planned: No
Related trials for Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
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 Pancreatitis, run by University of Minho at 1 site in Portugal.
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 6 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 30 Jul 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 Portugal. 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 Luís Lopes, MD, PhD, MBA (+351932841974, luis.m.lopes@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the morphology of the Vater's Ampulla and biliary cannulation difficulty (time frame: 1 day). 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 NCT04492124, which also lists 15 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 30 Jul 2020.