Chronic PancreatitisNCT06684301
Study on Predictive Factors, Safety and Efficacy of Endoscopic Retrograde Accessory Pancreatography in CP
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
Chronic pancreatitis (CP) can manifest characteristic pathological modifications such as pancreatic duct stenosis and pancreatic duct lithiasis. The endoscopic access to the main pancreatic duct through the major duodenal papilla is prevalently recognized as the most preponderant approach for endoscopic treatment of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 18 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in Changhai Hospital from 2022.09.15 to 2024.01.18.
Who may be able to join
- Patients with chronic pancreatitis hospitalized in Changhai Hospital from 2022.09.15 to 2024.01.18.
- Patients who completed endoscopic retrograde pancreatography.
- Aged 18 to 70 years,male or female.
Who cannot join
- Patients who accepted endoscopic retrograde pancreatography before.
- History of pancreatic surgery or Billroth II gastrectomy.
- Acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis
- Panceratic benign or malignant tumors.
- Pregnant or breastfeeding women.
- Patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Predictive Factors, Safety and Efficacy of Endoscopic Retrograde Accessory Pancreatography in Chronic Pancreatitis: a Prospective Cohort Study
Chronic pancreatitis (CP) can manifest characteristic pathological modifications such as pancreatic duct stenosis and pancreatic duct lithiasis. The endoscopic access to the main pancreatic duct through the major duodenal papilla is prevalently recognized as the most preponderant approach for endoscopic treatment of CP. Given that a multitude of CP patients are accompanied by main pancreatic duct stricture and distortion, certain patients encounter failure in main papilla angiography or are unable to achieve deep cannulation of the pancreatic duct, thus necessitating endoscopic retrograde accessory pancreatic ductography via the accessory papilla to augment the success rate of endoscopic drainage. Presently, there lacks a large - scale case report concerning the proportion of patients receiving main and accessory pancreatic ductography treatment and the safety and efficacy of endoscopic retrograde accessory pancreatic ductography in the treatment of CP. This study endeavors to establish a prospective cohort to document the proportion of CP patients undergoing main and accessory pancreatic duct angiography treatment and their clinical features during the initial endoscopic retrograde pancreatography (ERP). The main analysis centers on identifying the predictive factors for resorting to accessory pancreatic duct treatment subsequent to the failure of primary pancreatic duct angiography and assessing the safety and efficacy of endoscopic retrograde accessory pancreatic ductography in the treatment of CP.
Read the detailed description
In recent years, with the development of endoscopic retrograde cholangiopancreatography (ERCP) technology, therapeutic ERCP has emerged as a first - line therapeutic modality for CP owing to its advantages of minimal invasiveness and high-level safety. The endoscopic access to the main pancreatic duct through the major duodenal papilla is commonly recognized as the preponderant approach for endoscopic treatment of CP. Nevertheless, in clinical practice, it has been observed that in a portion of CP patients, due to pancreatic divisum, distortion or stricture of the main pancreatic duct or other reasons, either the main papilla angiography fails or deep cannulation of the pancreatic duct cannot be achieved, thereby necessitating endoscopic retrograde accessory pancreatic ductography via the minor papilla. Previously, two small-sample retrospective studies analyzed the scenarios where CP patients with main pancreatic duct obstruction resulting from calculi, stenosis, etc. required attempts at accessory pancreatic ductography. The results demonstrated favorable safety and efficacy of accessory pancreatic duct treatment. In this prospective study, CP patients undergoing ERP for the first time in the pancreatic disease area of the Gastroenterology Department of Changhai Hospital were enrolled. After routine main papilla angiography, those with failed treatment via the main pancreatic duct were subjected to an attempt at endoscopic retrograde accessory pancreatic ductography through the minor papilla. Based on the distinct endoscopic retrograde angiography modalities and treatment outcomes in clinical practice, different subgroups were established. The number of cases receiving treatment via the main and accessory pancreatic ducts was tallied respectively. The clinical features of CP patients with successful main pancreatic duct drainage and those with failed drainage were compared. Emphasis was placed on analyzing the predictive factors for CP patients with failed main pancreatic duct angiography who then attempted accessory pancreatic duct angiography, as well as evaluating the safety and clinical efficacy of endoscopic retrograde accessory pancreatic ductography in CP patients.
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic Pancreatitis, Endoscopic Retrograde Pancreatography, Accessory Pancreatic Duct, Technical Success, Complication
- Medical subject headings
- Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of accessory pancreatic ductography.
The success rate of accessory pancreatic ductography is the percentage of successful imaging operations of the accessory pancreatic duct, crucial for assessing the efficacy of relevant procedures.
Measured: during ERCP procedure
Secondary outcomes (2)
post-ERCP complications
Major post-ERCP complications includes post-ERCP pancreatitis, bleeding, infection, and perforation, which are classified as mild, moderate, or severe, depending mainly on the length of hospitalization and the need for invasive treatment.
Measured: 30 days after ERCP procedure
clearance rates of pancreatic duct stones
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was > 90%, 50% - 90%, or < 50%, respectively
Measured: during ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Sep 2022
- Primary completion18 Jan 2024
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684301
- Sponsor's protocol ID
- CHEC2022-238
- Status last verified
- May 2024
- First submitted
- 10 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tringali A, Voiosu T, Schepis T, Landi R, Perri V, Bove V, Voiosu AM, Costamagna G. Pancreas divisum and recurrent pancreatitis: long-term results of minor papilla sphincterotomy. Scand J Gastroenterol. 2019 Mar;54(3):359-364. doi: 10.1080/00365521.2019.1584640. Epub 2019 Mar 17.
PubMed 30880501Brown NG, Howell DA, Brauer BC, Walker J, Wani S, Shah RJ. Minor papilla endotherapy in patients with ventral duct obstruction: identification and management. Gastrointest Endosc. 2017 Feb;85(2):365-370. doi: 10.1016/j.gie.2016.07.066. Epub 2016 Aug 13.
PubMed 27530069Kwon CI, Gromski MA, Sherman S, El Hajj II, Easler JJ, Watkins J, McHenry L, Lehman GA, Fogel EL. Clinical response to dorsal duct drainage via the minor papilla in refractory obstructing chronic calcific pancreatitis. Endoscopy. 2017 Apr;49(4):371-377. doi: 10.1055/s-0042-120996. Epub 2017 Feb 15.
PubMed 28201840Moffatt DC, Cote GA, Avula H, Watkins JL, McHenry L, Sherman S, Lehman GA, Fogel EL. Risk factors for ERCP-related complications in patients with pancreas divisum: a retrospective study. Gastrointest Endosc. 2011 May;73(5):963-70. doi: 10.1016/j.gie.2010.12.035. Epub 2011 Mar 9.
PubMed 21392753
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Predictive Factors, Safety and Efficacy of Endoscopic Retrograde Accessory Pancreatography in Chronic Pancreatitis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06684301
- Acronym / sponsor ID
- CHEC2022-238
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic Pancreatitis, Endoscopic Retrograde Pancreatography, Accessory Pancreatic Duct, Technical Success, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 12 Nov 2024 (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.
Chronic pancreatitis (CP) can manifest characteristic pathological modifications such as pancreatic duct stenosis and pancreatic duct lithiasis. The endoscopic access to the main pancreatic duct through the major duodenal papilla is prevalently recognized as the most preponderant approach for endoscopic treatment of CP. Given that a multitude of CP patients are accompanied by main pancreatic duct stricture and distortion, certain patients encounter failure in main papilla angiography or are unable to achieve deep cannulation of the pancreatic duct, thus necessitating endoscopic retrograde accessory pancreatic ductography via the accessory papilla to augment the success rate of endoscopic drainage. Presently, there lacks a large - scale case report concerning the proportion of patients receiving main and accessory pancreatic ductography treatment and the safety and efficacy of endoscopic retrograde accessory pancreatic ductography in the treatment of CP. This study endeavors to establish a prospective cohort to document the proportion of CP patients undergoing main and accessory pancreatic duct angiography treatment and their clinical features during the initial endoscopic retrograde pancreatography (ERP). The main analysis centers on identifying the predictive factors for resorting to accessory pancreatic duct treatment subsequent to the failure of primary pancreatic duct angiography and assessing the safety and efficacy of endoscopic retrograde accessory pancreatic ductography in the treatment of CP.
Detailed description
In recent years, with the development of endoscopic retrograde cholangiopancreatography (ERCP) technology, therapeutic ERCP has emerged as a first - line therapeutic modality for CP owing to its advantages of minimal invasiveness and high-level safety. The endoscopic access to the main pancreatic duct through the major duodenal papilla is commonly recognized as the preponderant approach for endoscopic treatment of CP. Nevertheless, in clinical practice, it has been observed that in a portion of CP patients, due to pancreatic divisum, distortion or stricture of the main pancreatic duct or other reasons, either the main papilla angiography fails or deep cannulation of the pancreatic duct cannot be achieved, thereby necessitating endoscopic retrograde accessory pancreatic ductography via the minor papilla. Previously, two small-sample retrospective studies analyzed the scenarios where CP patients with main pancreatic duct obstruction resulting from calculi, stenosis, etc. required attempts at accessory pancreatic ductography. The results demonstrated favorable safety and efficacy of accessory pancreatic duct treatment. In this prospective study, CP patients undergoing ERP for the first time in the pancreatic disease area of the Gastroenterology Department of Changhai Hospital were enrolled. After routine main papilla angiography, those with failed treatment via the main pancreatic duct were subjected to an attempt at endoscopic retrograde accessory pancreatic ductography through the minor papilla. Based on the distinct endoscopic retrograde angiography modalities and treatment outcomes in clinical practice, different subgroups were established. The number of cases receiving treatment via the main and accessory pancreatic ducts was tallied respectively. The clinical features of CP patients with successful main pancreatic duct drainage and those with failed drainage were compared. Emphasis was placed on analyzing the predictive factors for CP patients with failed main pancreatic duct angiography who then attempted accessory pancreatic duct angiography, as well as evaluating the safety and clinical efficacy of endoscopic retrograde accessory pancreatic ductography in CP patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Changhai Hospital from 2022.09.15 to 2024.01.18.
Key inclusion criteria (3 listed)
- Patients with chronic pancreatitis hospitalized in Changhai Hospital from 2022.09.15 to 2024.01.18.
- Patients who completed endoscopic retrograde pancreatography.
- Aged 18 to 70 years,male or female.
Key exclusion criteria (6 listed)
- Patients who accepted endoscopic retrograde pancreatography before.
- History of pancreatic surgery or Billroth II gastrectomy.
- Acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis
- Panceratic benign or malignant tumors.
- Pregnant or breastfeeding women.
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
Success rate of accessory pancreatic ductography.
Time frame: during ERCP procedure
The success rate of accessory pancreatic ductography is the percentage of successful imaging operations of the accessory pancreatic duct, crucial for assessing the efficacy of relevant procedures.
2 secondary outcomes
post-ERCP complications
Time frame: 30 days after ERCP procedure
clearance rates of pancreatic duct stones
Time frame: during ERCP procedure
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 12 Nov 2024.
- Background: PubMed 30880501Tringali A, Voiosu T, Schepis T, Landi R, Perri V, Bove V, Voiosu AM, Costamagna G. Pancreas divisum and recurrent pancreatitis: long-term results of minor papilla sphincterotomy. Scand J Gastroenterol. 2019 Mar;54(3):359-364. doi: 10.1080/00365521.2019.1584640. Epub 2019 Mar 17.
- Background: PubMed 27530069Brown NG, Howell DA, Brauer BC, Walker J, Wani S, Shah RJ. Minor papilla endotherapy in patients with ventral duct obstruction: identification and management. Gastrointest Endosc. 2017 Feb;85(2):365-370. doi: 10.1016/j.gie.2016.07.066. Epub 2016 Aug 13.
- Background: PubMed 28201840Kwon CI, Gromski MA, Sherman S, El Hajj II, Easler JJ, Watkins J, McHenry L, Lehman GA, Fogel EL. Clinical response to dorsal duct drainage via the minor papilla in refractory obstructing chronic calcific pancreatitis. Endoscopy. 2017 Apr;49(4):371-377. doi: 10.1055/s-0042-120996. Epub 2017 Feb 15.
- Background: PubMed 21392753Moffatt DC, Cote GA, Avula H, Watkins JL, McHenry L, Sherman S, Lehman GA, Fogel EL. Risk factors for ERCP-related complications in patients with pancreas divisum: a retrospective study. Gastrointest Endosc. 2011 May;73(5):963-70. doi: 10.1016/j.gie.2010.12.035. Epub 2011 Mar 9.
- Individual participant dataSharing planned: No
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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.
Liang-hao Hu, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 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: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Success rate of accessory pancreatic ductography. (time frame: during 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 NCT06684301, which also lists 4 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 12 Nov 2024.