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The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis

NCT ID: NCT01610193

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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

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Appendicitis Abdominal Pain Abdominal Sepsis

Keywords

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Pancreatic Stone Protein Abdominal pain Acute appendicitis Alvarado score Appendectomy Sensitivity and specificity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Right sided abdominal pain

Patients that present at the Emergency Department with abdominal pain and a clinical suspicion of appendicitis.

Appendicectomy

Intervention Type PROCEDURE

Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.

Interventions

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Appendicectomy

Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.

Intervention Type PROCEDURE

Other Intervention Names

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Appendectomy or appendisectomy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laikο General Hospital, Athens

OTHER

Sponsor Role collaborator

University of Athens

OTHER

Sponsor Role collaborator

Kantonsspital Münsterlingen

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dimitri A Raptis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Surgery

Rolf Graf, PhD

Role: STUDY_CHAIR

University Hospital Zurich, Department of Surgery

Locations

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University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

University Hospital Zurich, Department of Surgery

Zurich, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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Switzerland

Central Contacts

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Dimitri A Raptis, MD, MSc

Role: CONTACT

Phone: +41798820542

Email: [email protected]

Rolf Graf, PhD

Role: CONTACT

Phone: +41442553041

Email: [email protected]

Facility Contacts

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Dimitri A Raptis, MD, MSc

Role: primary

Rolf Graf, PhD

Role: backup

Dimitri A Raptis, MD, MSc

Role: primary

Rolf Graf, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 3963537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21835904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19325491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16360171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9006958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21867979 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21804274 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23098130 (View on PubMed)

Other Identifiers

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PSP_Appendix

Identifier Type: -

Identifier Source: org_study_id