AppendicitisNCT01610193
The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis
An observational study of Appendicitis and Abdominal Pain, run by University of Zurich at 2 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis, Abdominal Pain, Abdominal Sepsis
- What is being tested?
- Appendicectomy
- Type of treatment
- Surgery or procedure
- How many people
- 245 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that will present at the emergency department with abdominal pain and a clinical suspicion of acute appendicitis.
Who may be able to join
- Age >18 years of age (subject to the current ethics approval protocol, may change)
- Clinical suspicion of appendicitis as the primary or differential diagnoses
- Patients able to provide informed consent
Who cannot join
- Age <18 years of age (subject to the current ethics approval protocol, may change)
- Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis
- Pregnancy
- Patients with impaired consciousness
- Patients not able to provide informed consent
- Patients that will receive an appendicectomy as part of another elective procedure
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Dimitri A Raptis, MD, MSc, +41798820542, dimitri.raptis@usz.ch
Rolf Graf, PhD, rolf.graf@usz.ch
- Not yet recruiting
University Hospital Zurich, Department of Surgery
Zurich, CH-8091
Dimitri A Raptis, MD, MSc, +41798820542, dimitri.raptis@usz.ch
Rolf Graf, PhD, +41442553041, rolf.graf@usz.ch
About this study
Official title: The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain
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.
Read the detailed description
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
- Conditions
- Appendicitis, Abdominal Pain, Abdominal Sepsis
- Being tested
- Appendicectomy
- Keywords
- Pancreatic Stone Protein, Abdominal pain, Acute appendicitis, Alvarado score, Appendectomy, Sensitivity and specificity
- Medical subject headings
- Appendicitis, Abdominal Pain, Intraabdominal Infections, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendicectomyProcedure or surgery
Also called Appendectomy or appendisectomy
Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.
| Study group | Role | What they receive |
|---|---|---|
| Right sided abdominal pain | Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis. Receives: Procedure: Appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of PSP in diagnosing appendicitis
ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis
Measured: 1 day
Secondary outcomes (5)
Accuracy of CRP in diagnosing appendicitis
ROC Curve analysis and predictive value of CRP (C-Reactive Protein) in diagnosing appendicitis
Measured: 1 day
Accuracy of WCC in diagnosing appendicitis
ROC Curve analysis and predictive value of WCC (White Cell Count) in diagnosing appendicitis
Measured: 1 day
Accuracy of the "Alvarado Score" in diagnosis appendicitis
ROC Curve analysis and predictive value of Alvarado Score in diagnosing appendicitis
Measured: 1 day
Accuracy of USS in diagnosing appendicitis
ROC Curve analysis and predictive value of Ultrasound Scanning (USS) in diagnosing appendicitis, most commonly performed in young females
Measured: 1 day
Accuracy of CT in diagnosing appendicitis
ROC Curve analysis and predictive value of CT (Computer Tomography) in diagnosing appendicitis, most commonly performed in the elderly
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Laikο General Hospital, Athens, University of Athens, Kantonsspital Münsterlingen
- Responsible party
- Sponsor
- Investigators
- Dimitri A Raptis, MD, MSc, Principal investigator, University Hospital Zurich, Department of SurgeryRolf Graf, PhD, Study chair, University Hospital Zurich, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610193
- Sponsor's protocol ID
- PSP_Appendix
- Status last verified
- Aug 2013
- First submitted
- 30 May 2012
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 3963537Clavien 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.
PubMed 19638912Boeck 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.
PubMed 21835904Keel 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.
PubMed 19325491Graf 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.
PubMed 16360171Bimmler 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.
PubMed 9006958Planas 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.
PubMed 21867979Jin 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.
PubMed 21804274Tschuor 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.
PubMed 23098130
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis in Patients Presenting at the Emergency Department With Abdominal Pain
- ClinicalTrials.gov ID
- NCT01610193
- Acronym / sponsor ID
- PSP_Appendix
- Conditions
- Appendicitis, Abdominal Pain, Abdominal Sepsis
- Keywords
- Pancreatic Stone Protein, Abdominal pain, Acute appendicitis, Alvarado score, Appendectomy, Sensitivity and specificity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Laikο General Hospital, Athens, University of Athens, Kantonsspital Münsterlingen
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right sided abdominal pain | – | Procedure: AppendicectomyPatients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that will present at the emergency department with abdominal pain and a clinical suspicion of acute appendicitis.
Key inclusion criteria (3 listed)
- Age >18 years of age (subject to the current ethics approval protocol, may change)
- Clinical suspicion of appendicitis as the primary or differential diagnoses
- Patients able to provide informed consent
Key exclusion criteria (6 listed)
- Age <18 years of age (subject to the current ethics approval protocol, may change)
- Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis
- Pregnancy
- Patients with impaired consciousness
- Patients not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendicectomyAlso: Appendectomy or appendisectomyAlso known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open. | Procedure or surgery | Right sided abdominal pain |
Primary outcome
Accuracy of PSP in diagnosing appendicitis
Time frame: 1 day
ROC Curve analysis and predictive value of PSP (Pancreatic Stone Protein) in diagnosing appendicitis
5 secondary outcomes
Accuracy of CRP in diagnosing appendicitis
Time frame: 1 day
Accuracy of WCC in diagnosing appendicitis
Time frame: 1 day
Accuracy of the "Alvarado Score" in diagnosis appendicitis
Time frame: 1 day
Accuracy of USS in diagnosing appendicitis
Time frame: 1 day
Accuracy of CT in diagnosing appendicitis
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Background: PubMed 3963537Alvarado 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.
- Background: PubMed 19638912Clavien 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.
- Background: PubMed 21835904Boeck 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.
- Background: PubMed 19325491Keel 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.
- Background: PubMed 16360171Graf 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.
- Background: PubMed 9006958Bimmler 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.
- Background: PubMed 21867979Planas 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.
- Background: PubMed 21804274Jin 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.
- Derived from this study: PubMed 23098130Tschuor 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.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri A Raptis, MD, MSc principal investigator
University Hospital Zurich, Department of Surgery
Rolf Graf, PhD study chair
University Hospital Zurich, Department of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Abdominal Pain, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitri A Raptis, MD, MSc (+41798820542, dimitri.raptis@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of PSP in diagnosing appendicitis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01610193, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.