Metabolic Impact of Pancreatic Duct Decompression
Metabolic Impact of Endoscopic Pancreatic Duct Decompression: A Pilot Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This single-center randomized controlled trial will compare endoscopic pancreatic duct decompression with medical management alone for the treatment of pancreatic duct obstruction in patients with minimally symptomatic chronic pancreatitis. Utilizing mixed-meal tolerance testing, endocrine function will be assessed at baseline and 6-months post-randomization. We hypothesize that rigorous metabolic testing using mixed-meal tolerance testing at baseline and 6-months post-randomization will be feasible.
The study intervention entails endoscopic pancreatic duct decompression which entails endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shock wave lithotripsy (ESWL). Endoscopic treatment via ERCP ± ESWL will continue until pancreatic duct decompression is achieved. The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Luis Ospina, BS
- Telefoonnummer: 507-538-1827
- E-mail: OspinaVelasquez.Luis@mayo.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18
- Chronic pancreatitis as defined by Cambridge grade 3 or 4 (3: > 3 abnormal side branches; 4: abnormal main duct and branches) pancreatic ductal changes and/or parenchymal and/or intraductal calcifications (chronic calcific pancreatitis) by CT Scan or MRI/MRCP24
Minimally symptomatic:
- Asymptomatic patients who were incidentally diagnosed with chronic pancreatitis based on imaging
- Mild to moderate pain (visual analog scale ≤ 5) who do not require daily opioid pain medications
- ≤ 1 episode of uncomplicated acute pancreatitis in 12 months prior to enrollment
Exclusion Criteria:
- History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL)
- Pancreatic duct obstruction limited to the tail of pancreas
- Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy)
- Prior pancreatic surgery
- Pancreatic head mass or suspicion for pancreatic malignancy
- Concurrent extra-pancreatic malignancy other than non-melanoma skin cancer
- Prior endoscopic therapy for pancreatic duct obstruction
- Acute pancreatitis < 90 days prior to enrollment
- Active alcohol use within 2 months of enrollment
- Gastrointestinal stricture/obstruction precluding passage of the duodenoscope to the papilla
- Standard contraindications to ERCP
- Unable to receive general anesthesia
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Endoscopic pancreatic duct decompression (Intervention Arm)
Participants in the intervention arm will receive endoscopic pancreatic duct decompression.
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The study intervention is endoscopic pancreatic duct decompression, which will consist of endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shockwave lithotripsy (ESWL).
Treatment via ERCP +/- ESWL can be continued for multiple treatment sessions until the pancreatic duct has been decompressed, defined as complete resolution of the PD stricture (defined as > 90% resolution of the stenosis on pancreatography) and/or complete stone clearance (> 90% removal of PD stones) of any PD stones.
Pancreatoscopy-guided lithotripsy can be performed during ERCP as well to help aid in stricture or stone therapy.
|
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Geen tussenkomst: No endoscopic intervention (Control Arm)
The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility of performing randomized-controlled trial in patients with minimally symptomatic chronic pancreatitis to assess metabolic function as defined via enrollment ratio, retention rate, and assessment completion rate.
Tijdsspanne: From enrollment to 6 months post-randomization
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Feasibility will be defined as follows: For the study enrollment ratio, the total number of participants referred will form the denominator for the enrollment ratio, while the number of enrolled will form the numerator for the enrollment ratio. A 50% enrollment ratio will be indicative of feasibility. Retention will be determined by the proportion of enrolled participants who remain in the study until completion of endotherapy and the end of assessment period. A 75% retention rate will be indicative of feasibility. Assessment completion will be defined as completion of all baseline assessments and 6-months post-randomization assessments, including all metabolic tests. Participants who complete all assessments represent the numerators in the assessment completion ratio with the number of participants enrolled serving as the denominator in the assessment completion ratio. A 70% completion rate will indicate feasibility. |
From enrollment to 6 months post-randomization
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.
Tijdsspanne: From enrollment to 6 months post-randomization
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The secondary endpoint will be the change in insulin secretion from baseline to 6-months post-randomization for each treatment arm. Insulin secretion will be measured using mixed meal tolerance testing, which will be performed at baseline and 6-months post-randomization, during which serum C-peptide, insulin and glucose levels will be measured. Insulin secretion will be calculated using the Area Under the Curve (AUC) of C-peptide. This will be calculated using the trapezoidal method. An AUC of the fasting serum glucose levels will be calculated in similar fashion. Insulin secretion will then be estimated by dividing the AUC for C-peptide by the AUC for glucose. |
From enrollment to 6 months post-randomization
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Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase.
Tijdsspanne: From enrollment to 6-months post-randomization
|
Another secondary objective is to evaluate the impact of pancreatic duct decompression on pancreatic exocrine function, as measured using the fecal elastase test.
The change in fecal elastase levels from baseline to 6-months post-randomization will be compared between treatment groups to assess the change in pancreatic exocrine function.
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From enrollment to 6-months post-randomization
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Samuel Han, MD, Mayo Clinic
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Pathologische processen
- Chronische ziekte
- Ziekte attributen
- Metabole ziekten
- Ziekten van het spijsverteringsstelsel
- Glucosemetabolismestoornissen
- Alvleesklier Ziekten
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Pancreatitis
- Pancreatitis, chronisch
- Suikerziekte
Andere studie-ID-nummers
- 26-005624
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
Researchers will be able to access the IPD after submitting a proposal that is reviewed and approved by the PI.
Deidentified data in accordance to the agreed-upon proposal will be made available to researchers.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ANALYTIC_CODE
- MVO
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