Metabolic Impact of Pancreatic Duct Decompression
Metabolic Impact of Endoscopic Pancreatic Duct Decompression: A Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Luis Ospina, BS
- Numéro de téléphone: 507-538-1827
- E-mail: OspinaVelasquez.Luis@mayo.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.
Délai: From enrollment to 6 months post-randomization
|
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.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Samuel Han, MD, Mayo Clinic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies métaboliques
- Maladies du système digestif
- Troubles du métabolisme du glucose
- Maladies pancréatiques
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Pancréatite
- Pancréatite chronique
- Diabète sucré
Autres numéros d'identification d'étude
- 26-005624
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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