[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03632616":3,"trial-entities:NCT03632616":87,"trial-summary:NCT03632616":24},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":47,"minimum_age":48,"maximum_age":24,"healthy_volunteers":24,"eligibility_criteria":49,"std_ages":58,"locations":61,"central_contacts":79,"overall_officials":80,"references":85,"see_also_links":86},"NCT03632616","16-1816","Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions","Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis","UNKNOWN","2026-08-01","2024-05","2024-05-22","2017-07-01","University of Colorado, Denver","OTHER",false,"This study seeks to evaluate the effect of endoscopic interventions on quality of life in patients with chronic pancreatitis. Quality of life will be evaluated using the PANQOLI, a validated quality of life instrument specific to chronic pancreatitis. Endoscopic interventions will include pancreatic duct dilation and stenting, celiac plexus block, lithotripsy and removal of pancreatic duct stones, and pseudocyst drainage.","This is a multicenter prospective cohort study assessing the impact of endoscopic interventions on patients with chronic pancreatitis. Patients with chronic pancreatitis referred for endoscopic treatment, including pancreatic duct dilation and stenting, pseudocyst drainage, celiac plexus blocks, and pseudocyst drainage\u002Fnecrosectomy will be enrolled in this study. They will receive a baseline evaluation using the PANQOLI, a chronic pancreatitis-specific quality of life instrument, in addition to a visual analog scale to measure their pain. Demographic and endoscopic features will be collected in addition to pain medication use. Patients will receive follow-up at 1, 3, and 6 months post-intervention consisting of the PANQOLI, visual analog scale for pain, and pain medication use.",[19],"Chronic Pancreatitis",[21,22],"chronic pancreatitis","quality of life","OBSERVATIONAL",null,[],{"count":27,"type":28},500,"ESTIMATED",[30],{"type":14,"name":31,"description":32,"otherNames":33},"PANQOLI (quality of life instrument)","A quality of life instrument, the PANQOLI, will be administered prior to endoscopic intervention, and at 1,3, 6 and 12 months post-intervention.",[34],"Visual Analog Scale for pain",[36],{"measure":37,"description":38,"timeFrame":39},"Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)","The primary outcome will be the change in quality of life using the PANQOLI (PANcreatitis Quality of Life Instrument) after endoscopic intervention.","The outcome will be measured at 1, 3, and 6 months post-intervention.",[41,44],{"measure":42,"description":43,"timeFrame":39},"Change in pain level using the Visual Analog Scale (VAS) for pain.","The secondary outcome will include the change in pain using the Visual Analog Scale (VAS) for pain after endoscopic intervention",{"measure":45,"description":46,"timeFrame":39},"Change in pain medication use","The secondary outcome will include the change in pain medication use after endoscopic intervention.","ALL","18 Years",{"inclusion":50,"exclusion":52,"raw_text":57},[51],"Patients with painful chronic pancreatitis, defined as either 1) the presence of pancreatic calcifications on cross-sectional imaging, 2) morphologic changes consistent with the Rosemont criteria on endoscopic ultrasound, or 3) endoscopic pancreatic function test results consistent with decreased pancreatic function.",[53,54,55,56],"Pregnant females","Prisoners","Patients under the age of 18","Patients lacking the capacity to consent","Inclusion Criteria:\n\n* Patients with painful chronic pancreatitis, defined as either 1) the presence of pancreatic calcifications on cross-sectional imaging, 2) morphologic changes consistent with the Rosemont criteria on endoscopic ultrasound, or 3) endoscopic pancreatic function test results consistent with decreased pancreatic function.\n\nExclusion Criteria:\n\n* Pregnant females\n* Prisoners\n* Patients under the age of 18\n* Patients lacking the capacity to consent",[59,60],"ADULT","OLDER_ADULT",[62,71],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"University of Colorado Anschutz Medical Center","Aurora","Colorado","80045","United States",{"lat":69,"lon":70},39.72943,-104.83192,{"facility":72,"city":73,"state":74,"zip":75,"country":67,"geoPoint":76},"Johns Hopkins","Baltimore","Maryland","21287",{"lat":77,"lon":78},39.29038,-76.61219,[],[81],{"name":82,"affiliation":83,"role":84},"Raj J Shah, MD","Professor of Medicine; Director, Pancreas and Biliary Endoscopy","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":88,"biomarkers":89},[19],[]]