Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT01610193
Status:
UNKNOWN
Last Update Posted:
2013-08-23
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood and serum or plasma of 245 patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 245}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-30', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Independent predictors of appendicitis', 'timeFrame': '1 day', 'description': 'Multivariate analysis of to identify independent clinical, laboratory and imaging predictors of appendicitis'}], 'primaryOutcomes': [{'measure': 'Accuracy of PSP in diagnosing appendicitis', 'timeFrame': '1 day', 'description': 'ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis'}], 'secondaryOutcomes': [{'measure': 'Accuracy of CRP in diagnosing appendicitis', 'timeFrame': '1 day', 'description': 'ROC Curve analysis and predictive value of CRP (C-Reactive Protein) in diagnosing appendicitis'}, {'measure': 'Accuracy of WCC in diagnosing appendicitis', 'timeFrame': '1 day', 'description': 'ROC Curve analysis and predictive value of WCC (White Cell Count) in diagnosing appendicitis'}, {'measure': 'Accuracy of the "Alvarado Score" in diagnosis appendicitis', 'timeFrame': '1 day', 'description': 'ROC Curve analysis and predictive value of Alvarado Score in diagnosing appendicitis'}, {'measure': 'Accuracy of USS in diagnosing appendicitis', 'timeFrame': '1 day', 'description': 'ROC Curve analysis and predictive value of Ultrasound Scanning (USS) in diagnosing appendicitis, most commonly performed in young females'}, {'measure': 'Accuracy of CT in diagnosing appendicitis', 'timeFrame': '1 day', 'description': 'ROC Curve analysis and predictive value of CT (Computer Tomography) in diagnosing appendicitis, most commonly performed in the elderly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Stone Protein', 'Abdominal pain', 'Acute appendicitis', 'Alvarado score', 'Appendectomy', 'Sensitivity and specificity'], 'conditions': ['Appendicitis', 'Abdominal Pain', 'Abdominal Sepsis']}, 'referencesModule': {'references': [{'pmid': '3963537', 'type': 'BACKGROUND', 'citation': 'Alvarado A. A practical score for the early diagnosis of acute appendicitis. Ann Emerg Med. 1986 May;15(5):557-64. doi: 10.1016/s0196-0644(86)80993-3.'}, {'pmid': '19638912', 'type': 'BACKGROUND', 'citation': 'Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.'}, {'pmid': '21835904', 'type': 'BACKGROUND', 'citation': 'Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.'}, {'pmid': '19325491', 'type': 'BACKGROUND', 'citation': 'Keel M, Harter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6.'}, {'pmid': '16360171', 'type': 'BACKGROUND', 'citation': 'Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.'}, {'pmid': '9006958', 'type': 'BACKGROUND', 'citation': 'Bimmler D, Graf R, Scheele GA, Frick TW. Pancreatic stone protein (lithostathine), a physiologically relevant pancreatic calcium carbonate crystal inhibitor? J Biol Chem. 1997 Jan 31;272(5):3073-82. doi: 10.1074/jbc.272.5.3073.'}, {'pmid': '21867979', 'type': 'BACKGROUND', 'citation': 'Planas R, Pujol-Autonell I, Ruiz E, Montraveta M, Cabre E, Lucas-Martin A, Pujol-Borrell R, Martinez-Caceres E, Vives-Pi M. Regenerating gene Ialpha is a biomarker for diagnosis and monitoring of celiac disease: a preliminary study. Transl Res. 2011 Sep;158(3):140-5. doi: 10.1016/j.trsl.2011.04.004. Epub 2011 May 30.'}, {'pmid': '21804274', 'type': 'BACKGROUND', 'citation': 'Jin CX, Hayakawa T, Ko SB, Ishiguro H, Kitagawa M. Pancreatic stone protein/regenerating protein family in pancreatic and gastrointestinal diseases. Intern Med. 2011;50(15):1507-16. doi: 10.2169/internalmedicine.50.5362. Epub 2011 Aug 1.'}, {'pmid': '23098130', 'type': 'DERIVED', 'citation': 'Tschuor C, Raptis DA, Limani P, Bachler T, Oberkofler CE, Breitenstein S, Graf R. The value of pancreatic stone protein in predicting acute appendicitis in patients presenting at the emergency department with abdominal pain. BMC Gastroenterol. 2012 Oct 25;12:154. doi: 10.1186/1471-230X-12-154.'}]}, 'descriptionModule': {'briefSummary': 'PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and the gut. There is evidence from experimental and clinical trials that the levels of PSP in the blood rise in the presence of inflammation or infection. What is not yet well known about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.', 'detailedDescription': 'Interim analysis will be performed once 123 patients are recruited. A power analysis will be performed and the sample size re-calculated based on the actual and precise data collected. At interim analysis, the external data monitoring committee will decide upon the continuation or discontinuation of the trial, as well the potential need to modify the sample size. If any changes are suggested by the external data monitoring committee, the principal investigators will decide on the feasibility of the potential changes and submit a formal addendum to the ethics committee. No changes will be made to the protocol or study design unless first approved by the ethics committee. Any changes to the protocol approved by the ethics committee will be updated at clinicaltrials.gov'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that will present at the emergency department with abdominal pain and a clinical suspicion of acute appendicitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years of age (subject to the current ethics approval protocol, may change)\n* Clinical suspicion of appendicitis as the primary or differential diagnoses\n* Patients able to provide informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years of age (subject to the current ethics approval protocol, may change)\n* Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis\n* Pregnancy\n* Patients with impaired consciousness\n* Patients not able to provide informed consent\n* Patients that will receive an appendicectomy as part of another elective procedure'}, 'identificationModule': {'nctId': 'NCT01610193', 'briefTitle': 'The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain', 'orgStudyIdInfo': {'id': 'PSP_Appendix'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Right sided abdominal pain', 'description': 'Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.', 'interventionNames': ['Procedure: Appendicectomy']}], 'interventions': [{'name': 'Appendicectomy', 'type': 'PROCEDURE', 'otherNames': ['Appendectomy or appendisectomy'], 'description': "Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.", 'armGroupLabels': ['Right sided abdominal pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Dimitri A Raptis, MD, MSc', 'role': 'CONTACT', 'email': 'dimitri.raptis@usz.ch', 'phone': '+41798820542'}, {'name': 'Rolf Graf, PhD', 'role': 'CONTACT', 'email': 'rolf.graf@usz.ch'}, {'name': 'Dimitri A Raptis, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rolf Graf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8091', 'city': 'Zurich', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Dimitri A Raptis, MD, MSc', 'role': 'CONTACT', 'email': 'dimitri.raptis@usz.ch', 'phone': '+41798820542'}, {'name': 'Rolf Graf, PhD', 'role': 'CONTACT', 'email': 'rolf.graf@usz.ch', 'phone': '+41442553041'}, {'name': 'Dimitri A Raptis, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rolf Graf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christoph Tschuor, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christian E Oberkofler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefan Breitenstein, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Zurich, Department of Surgery', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Dimitri A Raptis, MD, MSc', 'role': 'CONTACT', 'email': 'dimitri.raptis@usz.ch', 'phone': '+41798820542'}, {'name': 'Rolf Graf, PhD', 'role': 'CONTACT', 'email': 'rolf.graf@usz.ch', 'phone': '+41442553041'}], 'overallOfficials': [{'name': 'Dimitri A Raptis, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Department of Surgery'}, {'name': 'Rolf Graf, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Zurich, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laikο General Hospital, Athens', 'class': 'OTHER'}, {'name': 'University of Athens', 'class': 'OTHER'}, {'name': 'Kantonsspital Münsterlingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}