Pancreatitis Clinical Trials
- CP
- ADULTS > 18 YEARS
- CA, USA
- SINGLE SITE
- TREATMENT
A Pilot Clinical Trial of Paricalcitol for Chronic Pancreatitis (ALLIANCE)
The proposed trial will examine the feasibility of testing the effect of the vitamin D analog, paricalcitol (also known as Zemplar), on health-related quality of life, imaging, and biomarkers in patients with chronic pancreatitis (CP).
This study is the initial stage of investigating whether Paricalcitol could benefit individuals with chronic pain, while also exploring specific markers to determine its effectiveness. It is our hope that paricalcitol treatment will improve symptoms and reduce the pain of chronic pancreatitis where there is currently no non-surgical option.
Cedars-Sinai Medical Center, Los Angeles, CA
Inclusion Criteria:
- Male or female, aged 18-75 at time of enrollment
- Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e. suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis.
- Ability to take oral medication and be willing to adhere to the dosing regimen
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 week after the end of Investigational Product administration
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- No prior pancreatic surgery
- No involvement in any interventional trials currently or within 6 months of enrollment
Exclusion Criteria:
- Pregnancy or lactation
- Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria)
- Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator’s opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up
- Currently incarcerated
- Inability to tolerate MRI
There will be four visits to the clinic over a 12-month period. Once in the beginning, at 6 months, and again at the end of the study after 12 months pass.
Name: Marissa Podell
Phone Number: 310-967-1109
Email: marissa.podell@cshs.org
Principal Investigator: Stephen Pandol, MD
- CP
- ADULTS > 18 YEARS
- MD, USA
- SINGLE SITE
- TREATMENT
Johns Hopkins Pancreatitis Pain Program
Johns Hopkins Pancreatitis Pain Program is a research and patient care program that brings pain relief and hope to patients with chronic pain caused by pancreatitis. In this program, a team of experts provide new pain treatments to help improve patients’ quality of life.
The Johns Hopkins team includes experts in different areas such as pain, digestion, and mental health, working together to reduce patient pain caused by pancreatitis. Their approach uses medications and therapies that work on nerves in your head and gut to treat your whole body. This program is one of the only places in the world to study the connection between mental health, pain, and pancreatitis.
Johns Hopkins Hospital (Meyer building), Baltimore, MD
Inclusion Criteria:
- Diagnosis of chronic pancreatitis for at least 12 weeks duration
- Completed blood tests and imaging
- Chronic abdominal pain that impacts your daily life
First Meeting: Information is gathered in tests and surveys. Doctors will give a treatment recommendation.
Follow-up Meetings: Every 3 to 4 months
End Date: Ongoing until patient opts out
Name: Coleman Brathwaite
Phone Number: 410-955-2343
- CP
- ADULTS > 18 YEARS
- USA
- MULTI-SITE
- TREATMENT
Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis (STTEPP)
The researchers plan to study lacosamide, an FDA-approved anti-epilepsy medication, in combination with opioid therapy in patients suffering from chronic abdominal pain due to chronic pancreatitis (CP).
The researchers believe that combining lacosamide with opioids will enhance the effectiveness of opioids in managing pain in patients with chronic pancreatitis (CP). This study will look into what the best dosage of lacosamide and opioid is to best manage pain in CP patients.
Stanford, California | Indianapolis, Indiana | Rochester, Minnesota | Columbus, Ohio | Pittsburgh, Pennsylvania
Inclusion Criteria:
- ≥ 18 years old at the time of informed consent;
- Suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain
- Patients must be maintained on an opioid (except methadone or suboxone) for 4 weeks prior to enrollment for treatment of abdominal pain related to pancreatitis, with a daily morphine equivalent dose of 20-120mg
- Ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment)
Exclusion Criteria:
- Treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent
- Rapidly escalating pain that requires hospitalization or intravenous opioid therapy
- Known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine
- Pregnant or breastfeeding
- Patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs
- Abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment
- Hospitalization for pancreatitis exacerbation or pain management within 90 days of enrollment
Study Visit 1: Baseline study assessments and questionnaires in-person and then 7 days of treatment
Study Visit 2: After 7-day treatment period, there will be a clinic visit on day 8. Similar assessments and questionnaires will be used.
Follow-up: phone visit will occur on day 21 to assess for adverse events and medication changes
Name: Evan L Fogel, MD
Phone Number: 317-944-2816
Email: efogel@iu.edu
Secondary Contact:
Name: Fletcher A White
Phone Number: 317-274-5164
Email: fawhite@iu.edu
- RAP
- ADULTS > 18 YEARS
- USA & CA
- MULTI-SITE
- PROCEDURE
SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)
The purpose of this study is to investigate if an endoscopy procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with Minor Papilla Endoscopic Sphincterotomy (miES) can reduce the risk of recurrent acute pancreatitis.
The goal of this study is to see if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy can lower the risk of pancreatitis or reduce the number of times patients with pancreas divisum get pancreatitis again. The researchers are looking for people diagnosed with pancreas divisum, who have had at least two episodes of pancreatitis, and might benefit from the ERCP with sphincterotomy procedure. If you fit this description, you may be eligible to take part in the study.
United States:Â
University of Arkansas for Medical Sciences, Little Rock, AR | Keck Hospital of USC, Los Angeles, CA | Cedars-Sinai, Los Angeles, CA | UCSF Medical Center, San Francisco, CA | Emory University Hospital, Atlanta, GA | Hospital Northwestern Memorial Hospital, Chicago, IL | IU Health University Hospital, Indianapolis, IN | Harvard Medical School, Boston, MA | University of Minnesota Medical Center Hospital, Minneapolis, MN | Saint Luke’s Hospital of Kansas City, Kansas City, MO | University of Rochester, Rochester, NY | OSU Wexner Medical Center, Columbus, OH | Oregon Health and Science University, Portland, OR | UPMC Presbyterian Hospital, Pittsburgh, PA | Medical University of South Carolina University Hospital, Charleston, SC | Methodist Dallas Medical Center, Dallas, TX | UVA Medical Center, Charlottesville, VA
Canada:Â
Health Sciences Centre, Winnipeg, MB, CanadaÂ
Inclusion Criteria:
- 18+
- Must have pancreas divisum
- Had 2 pancreatitis attacks (at least one in the past year)
Exclusion Criteria:
- A clear cause of your pancreatitis
- Previous ERCP with minor papilla sphincterotomy (cutting of the opening of the pancreatic duct)
Initial Start: ERCP or sham procedure
Follow-up Visits: 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months
Name: Gregory Cote, MD
Phone Number: 503-494-5255
Email: coteg@ohsu.edu
Principal Investigator: Gregory Cote, MD
- RAP & CP
- PATIENTS > 16 YEARS
- MN, USA
- SINGLE SITE
- PROCEDURE
Long-Term Islet Function and Impact after Total Pancreatectomy with Islet Autotransplant (LIFT)
The University of Minnesota is looking for people aged 16 and older who had their pancreas completely removed, with or without an islet transplant, between 5 and 20 years ago. They aim to increase their understanding of diabetes after pancreas surgery.
This study aims to find out the long-term effectiveness of islet grafts (transplants) and their impact on diabetes complications after total pancreatectomy and autologous islet transplantation (TPIAT). Researchers want to improve the understanding of the body’s long-term blood sugar control. They will measure islet graft function by checking C-peptide levels during mixed meal tolerance tests. Individuals who had a total pancreatectomy with and without islet transplantation at any hospital are encouraged to participate; however, those without islet transplantation are especially needed. Participants will be required to visit the University of Minnesota for 2-3 days of testing. The clinical trial will cover travel costs and pay participants.
University of Minnesota Twin Cities, Minneapolis, MN
Inclusion Criteria:
- 16 years or older who have had a total pancreatectomy with or without an islet transplant 5 to 20 years ago
- People who had a total pancreatectomy without islets at any center are particularly needed.
This study will include a single ‘visit’ spanning 2-3 days to complete multiple tests.
Program Officer:
Name: Peggy Ptacek
Phone Number: 612-626-5905
Email: vorwa001@umn.edu
- RAP & CP
- ADULTS > 18 YEARS
- MULTI-COUNTRY
- MULTI-SITE
- PROCEDURE
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
In this study, researchers will use Quantitative Sensory Testing (QST) to learn more about the patterns of pain in patients with Chronic Pancreatitis (CP), with the goal to predict therapy responses and improve treatment results.
QST is a new way of studying chronic pain in various diseases. Researchers will use it in this study to understand the pain patterns in patients with CP. QST uses a set of standardized tests to map out how the pain system works. QST could completely change how we treat CP patients and help predict treatment responses.
Aalborg, Denmark | Halle, Germany | Alicante, Spain | Budapest, Hungary | Hyderabad, India | New Dehli, India | Auckland, New Zealand | Boston, Massachusetts | Baltimore, Maryland | New York, New York | Cincinnati, Ohio | Columbus, Ohio | Pittsburgh, Pennsylvania | Dallas, Texas | Indianapolis, IndianaÂ
Inclusion Criteria:
- 18 years or older in age
- Suspected CPs Inclusion Criteria
- Pantients with a) Indeterminate CP (Cambridge 1 or 2 on CT scan or MRI/MRCP) who have abdominal pain without prior history of AP, or b) those with acute (AP) or recurrent acute pancreatitis (RAP) who have recovered from their attack(s) of AP, whose imaging studies are either normal or show changes consistent with Cambridge classification of 1 or 2, and they have ongoing abdominal pain. Both diabetic and non-diabetic patients will be allowed to enter the study.
- Patients must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).
- Definite Chronic Pancreatitis – Inclusion Criteria
- Patients will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4). Both diabetic and non-diabetic subjects will be allowed to enter the study.
Exclusion Criteria:
- Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Patients suffering from painful conditions other than pancreatitis or Sphincter of Oddi Dysfunction (SOD) type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Patients with known pregnancy at the time of enrollment.
- Patients who have previously undergone surgical intervention on their pancreas.
First Visit: QST Testing and questionnaire
Follow-up Visits: Patients undergoing endoscopic or surgical therapy will have follow-up testing consisting of the same tests at 1, 3, and 6 months post-procedure
Name: Anna Evans Phillips, MD
Phone Number: 412-647-2345
Email: evansac3@upmc.edu
- CP
- ADULTS > 18 YEARS
- USA
- MULTI-SITE
- PROCEDURE
Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Pancreatic Quantitative Sensory Testing (P-QST) is a new method of measuring pain sensitivity. In this clinical trial, they will test how well P-QST can predict pain improvement in patients with chronic pancreatitis (CP) after they receive endoscopic therapy or surgery.
Researchers will use the results from P-QST to create a tool to predict how a patient will respond to treatment. P-QST will be used to identify baseline pain before endoscopic therapy or decompressive surgery. The results will be used to test and create a model to estimate individual responses to treatment.
Indianapolis, Indiana | Baltimore, Maryland | Pittsburgh, Pennsylvania
Inclusion Criteria:
- Adult patients ≥ 18 years of age with definite CP undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain.
- Endoscopic therapy: Endoscopic Retrograde Cholangiopancreatography (ERCP) with pancreatic duct stone removal, stent placement, and/or stricture dilation, ± intraductal lithotripsy or Extracorporeal Shock Wave Lithotripsy (ESWL).
- Surgery: drainage procedures (Frey and Puestow operations)
Exclusion Criteria:
- Patients with chronic pain from conditions other than CP
- Patients who have had endoscopic therapy within the past 12 months
- Patients who have undergone prior pancreatic surgery
- Patients who have resective surgical procedure planned (eg. Whipple procedure, Total Pancreatectomy)
- Patients with peripheral sensory deficits
- Patients with known pregnancy at the time of study screening**
- Note: Women who become pregnant during the course of the study can no longer participate in P-QST testing.
First Visit: pre-procedure P-QST testing before scheduled treatment as directed by their treating gastroenterologist.Â
Follow-up Visits: Scheduled at 3, 6, and 12 months after the first endotherapy session or surgery.
Name: Anna Evans Phillips, MD
Phone Number: 412-647-2345
Email: evansac3@upmc.edu
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