Chronic PancreatitisPIPNCT05713344
Pain Phenotypes in Chronic Pancreatitis
An observational study of Chronic Pancreatitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Chronic pancreatitis (CP) is characterised by recurrent abdominal pain. The pathological hallmarks of CP is pancreatic stellate cell activation that results in persistent inflammation and progressive fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Clinical history, Clinical examination and Evaluation of quality of life
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to 28 Feb 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with documented CP will be screened for enrolment criteria. Those fulfilling criteria will be enrolled after written informed consent.
Who may be able to join
- At least 3 years of disease (chronic pancreatitis)
- Both genders
- Able to provide informed consent
Who cannot join
- Acute exacerbation of chronic pancreatitis
- Moderate to severe abdominal pain at the time of screening
- Pancreatic cancer or other malignancies
- Use of antidepressants, narcotics, and neuromodulators
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology Hospitals
Hyderabad, Telangana, 500032
Rupjyoti Talukdar, MD, FICP, AGAF, +917032804231, rup_talukdar@yahoo.com
Misbah Unnisa, PharmD, 8801782828, misbahunnisa96@gmail.com
About this study
Official title: Evaluation of Pain Phenotypes in Chronic Pancreatitis and Identification of Clinical Surrogates of Pancreatic Neuropathy
Chronic pancreatitis (CP) is characterised by recurrent abdominal pain. The pathological hallmarks of CP is pancreatic stellate cell activation that results in persistent inflammation and progressive fibrosis. It has been shown in various clinical and experimental studies that with disease progression there could be pancreatic neural inflammation, spinal sensitization and eventually alteration in the pain modulating architecture within the brain (widespread sensitization). These events result in different types of pain (nociceptive and neuropathic) in patients with CP, which may dynamically change during disease progression.
Since the treatment for different mechanisms are unique, it becomes important to identify the predominant type of pain. Recently, pancreatic quantitative sensory testing (P-QST) has emerged as a valuable tool to identify different types of sensitization. This facility is currently available only in select centers and is being conducted under research protocols.
Read more
In this study, we propose to: 1. evaluate the patterns of pain in CP and the triggers; 2. identify clinical surrogates of sensitization, i.e. neuropathic pain.
The ultimate goal is to apply the best possible pain management strategy based on our research findings for patients with CP in a personalised manner.
- Conditions
- Chronic Pancreatitis
- Being tested
- Clinical history, Clinical examination, Evaluation of quality of life, Evaluation of mental state, Pancreatic quantitative sensory testing
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical historyOther
Detailed clinical history including demographic details, pain details (character, pattern, location, change in character, involvement of new areas), duration of disease, co-morbidities, family history, adverse life events, sleep details, details of stress/anxiety.
Clinical examinationOther
Thorough clinical examination, anthropometric measurement, assessment of pain (Izbicki score, Visual analog scale, modified brief pain inventory, pain catastrophising score, painDetect)
Evaluation of quality of lifeOther
Use of the EORTC QLQ c30 with PAN 28 to evaluate quality of life
Evaluation of mental stateOther
Use of Beck depression inventory and Hospital Anxiety Depression score to evaluate depression and anxiety
Pancreatic quantitative sensory testingDiagnostic test
Pancreatic quantitative sensory testing will be performed to evaluate temporal summation, pain detection threshold, pain tolerance threshold, and conditioned pain modulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of pain
The type of pancreatic pain, i.e nociceptive or neuropathic will be determined
Measured: 18 months
Quality of life
EORTC QLQ c30 score
Measured: 18 months
Mental status
Depression and anxiety will be determined
Measured: 18 months
Neural sensitization
Presence of localised and widespread sensitisation will be determined.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Aug 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
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.
- 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, SIDS Hospital and Research Center, Surat, Aalborg University Hospital
- Responsible party
- Principal investigator, Rupjyoti Talukdar, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713344
- Sponsor's protocol ID
- PIPver01
- Acronym
- PIP
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drewes AM, Bouwense SAW, Campbell CM, Ceyhan GO, Delhaye M, Demir IE, Garg PK, van Goor H, Halloran C, Isaji S, Neoptolemos JP, Olesen SS, Palermo T, Pasricha PJ, Sheel A, Shimosegawa T, Szigethy E, Whitcomb DC, Yadav D; Working group for the International (IAP - APA - JPS - EPC) Consensus Guidelines for Chronic Pancreatitis. Guidelines for the understanding and management of pain in chronic pancreatitis. Pancreatology. 2017 Sep-Oct;17(5):720-731. doi: 10.1016/j.pan.2017.07.006. Epub 2017 Jul 13.
PubMed 28734722Faghih M, Phillips AE, Kuhlmann L, Afghani E, Drewes AM, Yadav D, Singh VK, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Pancreatic QST Differentiates Chronic Pancreatitis Patients into Distinct Pain Phenotypes Independent of Psychiatric Comorbidities. Clin Gastroenterol Hepatol. 2022 Jan;20(1):153-161.e2. doi: 10.1016/j.cgh.2020.10.036. Epub 2020 Oct 22.
PubMed 34108130Talukdar R, Reddy DN. Pain in chronic pancreatitis: managing beyond the pancreatic duct. World J Gastroenterol. 2013 Oct 14;19(38):6319-28. doi: 10.3748/wjg.v19.i38.6319.
PubMed 24151350Sarkar S, Sarkar P, M R, Hazarika D, Prasanna A, Pandol SJ, Unnisa M, Jakkampudi A, Bedarkar AP, Dhagudu N, Reddy DN, Talukdar R. Pain, depression, and poor quality of life in chronic pancreatitis: Relationship with altered brain metabolites. Pancreatology. 2022 Sep;22(6):688-697. doi: 10.1016/j.pan.2022.06.007. Epub 2022 Jun 8.
PubMed 35710761
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Phenotypes in Chronic Pancreatitis and Identification of Clinical Surrogates of Pancreatic Neuropathy
- ClinicalTrials.gov ID
- NCT05713344
- Acronym / sponsor ID
- PIP / PIPver01
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, SIDS Hospital and Research Center, Surat, Aalborg University Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 6 Feb 2023 (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) is characterised by recurrent abdominal pain. The pathological hallmarks of CP is pancreatic stellate cell activation that results in persistent inflammation and progressive fibrosis. It has been shown in various clinical and experimental studies that with disease progression there could be pancreatic neural inflammation, spinal sensitization and eventually alteration in the pain modulating architecture within the brain (widespread sensitization). These events result in different types of pain (nociceptive and neuropathic) in patients with CP, which may dynamically change during disease progression.
Since the treatment for different mechanisms are unique, it becomes important to identify the predominant type of pain. Recently, pancreatic quantitative sensory testing (P-QST) has emerged as a valuable tool to identify different types of sensitization. This facility is currently available only in select centers and is being conducted under research protocols.
In this study, we propose to: 1. evaluate the patterns of pain in CP and the triggers; 2. identify clinical surrogates of sensitization, i.e. neuropathic pain.
The ultimate goal is to apply the best possible pain management strategy based on our research findings for patients with CP in a personalised manner.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with documented CP will be screened for enrolment criteria. Those fulfilling criteria will be enrolled after written informed consent.
Key inclusion criteria (3 listed)
- At least 3 years of disease (chronic pancreatitis)
- Both genders
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Acute exacerbation of chronic pancreatitis
- Moderate to severe abdominal pain at the time of screening
- Pancreatic cancer or other malignancies
- Use of antidepressants, narcotics, and neuromodulators
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 |
|---|---|---|
| Clinical historyDetailed clinical history including demographic details, pain details (character, pattern, location, change in character, involvement of new areas), duration of disease, co-morbidities, family history, adverse life events, sleep details, details of stress/anxiety. | Other | – |
| Clinical examinationThorough clinical examination, anthropometric measurement, assessment of pain (Izbicki score, Visual analog scale, modified brief pain inventory, pain catastrophising score, painDetect) | Other | – |
| Evaluation of quality of lifeUse of the EORTC QLQ c30 with PAN 28 to evaluate quality of life | Other | – |
| Evaluation of mental stateUse of Beck depression inventory and Hospital Anxiety Depression score to evaluate depression and anxiety | Other | – |
| Pancreatic quantitative sensory testingPancreatic quantitative sensory testing will be performed to evaluate temporal summation, pain detection threshold, pain tolerance threshold, and conditioned pain modulation. | Diagnostic test | – |
Primary outcome
Type of pain
Time frame: 18 months
The type of pancreatic pain, i.e nociceptive or neuropathic will be determined
Quality of life
Time frame: 18 months
EORTC QLQ c30 score
Mental status
Time frame: 18 months
Depression and anxiety will be determined
Neural sensitization
Time frame: 18 months
Presence of localised and widespread sensitisation will be determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 28734722Drewes AM, Bouwense SAW, Campbell CM, Ceyhan GO, Delhaye M, Demir IE, Garg PK, van Goor H, Halloran C, Isaji S, Neoptolemos JP, Olesen SS, Palermo T, Pasricha PJ, Sheel A, Shimosegawa T, Szigethy E, Whitcomb DC, Yadav D; Working group for the International (IAP - APA - JPS - EPC) Consensus Guidelines for Chronic Pancreatitis. Guidelines for the understanding and management of pain in chronic pancreatitis. Pancreatology. 2017 Sep-Oct;17(5):720-731. doi: 10.1016/j.pan.2017.07.006. Epub 2017 Jul 13.
- Background: PubMed 34108130Faghih M, Phillips AE, Kuhlmann L, Afghani E, Drewes AM, Yadav D, Singh VK, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Pancreatic QST Differentiates Chronic Pancreatitis Patients into Distinct Pain Phenotypes Independent of Psychiatric Comorbidities. Clin Gastroenterol Hepatol. 2022 Jan;20(1):153-161.e2. doi: 10.1016/j.cgh.2020.10.036. Epub 2020 Oct 22.
- Background: PubMed 24151350Talukdar R, Reddy DN. Pain in chronic pancreatitis: managing beyond the pancreatic duct. World J Gastroenterol. 2013 Oct 14;19(38):6319-28. doi: 10.3748/wjg.v19.i38.6319.
- Background: PubMed 35710761Sarkar S, Sarkar P, M R, Hazarika D, Prasanna A, Pandol SJ, Unnisa M, Jakkampudi A, Bedarkar AP, Dhagudu N, Reddy DN, Talukdar R. Pain, depression, and poor quality of life in chronic pancreatitis: Relationship with altered brain metabolites. Pancreatology. 2022 Sep;22(6):688-697. doi: 10.1016/j.pan.2022.06.007. Epub 2022 Jun 8.
- 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.
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 Asian Institute of Gastroenterology, India at 1 site in India.
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 4 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 8 Feb 2023. 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 India. 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 Rupjyoti Talukdar, MD, FICP, AGAF (+917032804231, rup_talukdar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of pain (time frame: 18 months). 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 NCT05713344, 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 8 Feb 2023.