CLINICAL TRIAL

Treatment for Pancreatitis, Chronic

EnrollingByInvitation · 18+ · All Sexes · Aurora, CO

This study is evaluating whether ESWL or PPL is better for patients with chronic pancreatitis and refractory main pancreatic duct stones.

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About the trial for Pancreatitis, Chronic

Eligible Conditions
Pancreatitis, Chronic · Pancreatitis

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Per-oral Pancreatoscopy-guided Lithotripsy
PROCEDURE
Control Group 2
Extracorporeal Shock-Wave Lithotripsy
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Pancreatitis, Chronic or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
This study involved subjects aged 18-80. show original
Subjects must have had at least one failed attempt at removing PD stones using standard ERP. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At the conclusion of treatment success/failure at 1,3,6, and 12 months follow-up.
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Pancreatitis, Chronic. Measurement will happen over the course of Up to 4 hours (four 1-hour sessions).

Stone Clearance Rate
UP TO 4 HOURS (FOUR 1-HOUR SESSIONS)
The rate of complete clearance of the main pancreatic duct of all stones.
Change in Pain Levels as Measured Using the COMPAT Score
AT THE CONCLUSION OF TREATMENT SUCCESS/FAILURE AT 1,3,6, AND 12 MONTHS FOLLOW-UP
Change in pain levels as measured using the comprehensive pain assessment tool, (COMPAT), a chronic pancreatitis-specific pain questionnaire. The questionnaire consists of 23 questions. A score is assessed for question # 14, which consists of 28 questions with scores ranging from 0 to 10, with 10 representing worse pain. A maximum score of 280 is possible for this component of the COMPAT.
Change In Quality of Life as Measured Using PANQOLI Score
AT THE CONCLUSION OF TREATMENT SUCCESS/FAILURE AT 1,3,6, AND 12 MONTHS FOLLOW-UP
Change in quality of life as measured using the PANQOLI (PANcreatitis Quality of Life Instrument), a chronic pancreatitis-specific quality of life instrument. This instrument has a score range from 0 to 100, which higher scores denoting better quality of life. The questionnaire has 18 items and questions 1, 2, 3, 4, 5, 6, 12, 13, 14, 15, 16, 17, and 18 are reverse scored while items 7, 8, 9, 10, and 11 are scored at face value. The final score is the sum of the scores from all 18 questions.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is pancreatitis, chronic?

In chronic alcoholic pancreatitis, there is chronic pancreatic inflammation and progressive fibrosis. Histologic patterns include chronic inflammatory pseudocysts. Chronic pancreatitis is a risk factor for pancreatic cancer, and may therefore behave like other chronic pancreatic diseases like diabetes, renal disease, atherosclerosis and COPD. Chronic pancreatitis has often been confused with multiple pancreatic diseases, and may be misdiagnosed.

Anonymous Patient Answer

What are the signs of pancreatitis, chronic?

Patients with CP may have several signs and symptoms, which may not include abdominal pain, nausea/vomiting, or jaundice. However, pancreatitis remains a leading cause of morbidity and mortality because of the poor prognosis of CP. A timely diagnosis and prompt treatment are indispensable for improving the clinical outcomes of patients with CP.

Anonymous Patient Answer

What are common treatments for pancreatitis, chronic?

Recent findings provides a review of the management of patients with pancreatitis with a focus on the management of complications of the disease. Patients with symptomatic pancreatitis may be treated with non-specific and broad-spectrum antibiotics, steroids and the prophylactic administration of antibiotics is recommended in patients with infectious complications. Gastroenterologists should be consulted in patients presenting with abdominal pain and a positive stool examination. Inpatient physiotherapy is helpful as is management with analgesics, as analgesics may be beneficial for long term maintenance of an altered pancreas function and prevention of pancreatic fistula. Injection of a number of agents into the pancreas are used as a treatment option, with the most common being corticosteroids.

Anonymous Patient Answer

What causes pancreatitis, chronic?

Factors causing chronic pancreatitis include increased workload and prolonged exposure to harmful vapors at work and smokeless tobacco. The number of alcoholic beverages consumed is a major risk factor, but neither age nor sex has a significant effect.

Anonymous Patient Answer

Can pancreatitis, chronic be cured?

Although the overall survival of patients with CP is poor, some patients have been able to survive many years with a satisfactory quality of life.

Anonymous Patient Answer

How many people get pancreatitis, chronic a year in the United States?

Around 19.8 million Americans are affected with chronic pancreatitis annually, making it the ninth leading cause of disability in the US. Patients suffer at the highest costs in the United States, with average costs around $64,000 per year for management.

Anonymous Patient Answer

What is treatment?

[There are several treatments available for the chronic phase of pancreatitis, but there are no definite guidelines (http://www.jdrf.org.uk/treatments.aspx) as to what treatment should be given in any particular patient]. Inpatient observation and analgesia are the most often used treatments in the acute phase of pancreatitis. Inpatient observation often involves lying-in-bed as opposed to a hospital bed to aid recovery from pancreatic disease and to protect the patient from worsening complications.

Anonymous Patient Answer

How does treatment work?

Recent findings demonstrate that treatment of chronic pancreatitis is worthwhile. Recent findings also suggest a role for lifestyle modification as well as pharmacotherapy. Further long-term studies are warranted to support these findings.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

In our population, patients with chronic pancreatitis were exposed to a greater number of clinical trials compared with healthy control subjects. This trial selection bias might be an explanation for the observed improvements in clinical outcomes and decreased hospitalizations in clinical practice trials. Clinical trials in chronic pancreatitis can be difficult to implement due to the disease's chronicity and the long time durations required to obtain clinical outcomes, and further studies are needed to test whether trials in chronic pancreatitis are more effective in general than in randomized control trials.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Patients who have been treated with combination therapy have worse long-term outcomes than patients who will receive monotherapy. The majority of the patients can be stabilized with only one or two drugs; this observation supports a multidisciplinary approach to the management of chronic pancreatitis.

Anonymous Patient Answer

Does treatment improve quality of life for those with pancreatitis, chronic?

QOL improved following treatment of severe chronic pancreatitis. However, treatment did not result in substantial improvements in any of the 4 dimensions of the SF-36. Although treatment, when used, does not enhance QOL in chronic pancreatitis, treatment can provide a valuable means of coping with disease.

Anonymous Patient Answer

What are the common side effects of treatment?

There are many common adverse events that can occur as a side effect during the 6 months of treatment with infliximab. These side effects are generally mild in nature with minimal treatment-associated morbidity.

Anonymous Patient Answer
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