Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Peritoneal Cancer Clinical Trial

Official title:

Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02741167
• Other study ID #: HIPEC 2015-0529
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2016
• Last updated: May 3, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: Kuno Lehmann, MD, PhD
• Phone: +41 44 255 23 04
• Email: kuno.lehmann[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the dynamics of inflammatory parameters in presence or absence of infectious complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Description:

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the treatment of choice in patients with primary or secondary peritoneal surface malignancies. However the survival benefit is achieved at the cost of increased morbidity and mortality due to an extensive surgery and intraoperative chemo-therapy. Among complications infectious complications are the most common. The early diagnosis of a potential fatal infection is therefore crucial to ensure a good outcome in patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive adult patients (more than 18 years) subjected to CRS and HIPEC due to peritoneal malignancy.

• Written informed consent by the participant after information about the research project

Exclusion Criteria:

• No primary or secondary peritoneal surface malignancy

• No CRS and HIPEC

• Pregnancy

• Younger than 18 years

Related Conditions & MeSH terms

• Fever
• Inflammation
• Peritoneal Cancer

Intervention

Procedure:
• CRS and HIPEC
During CRS, all visible peritoneal tumors are removed. Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy

Locations

Country	Name	City	State
Switzerland	Division of Visceral Surgery and Transplantation , University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Capone A, Valle M, Proietti F, Federici O, Garofalo A, Petrosillo N. Postoperative infections in cytoreductive surgery with hyperthermic intraperitoneal intraoperative chemotherapy for peritoneal carcinomatosis. J Surg Oncol. 2007 Nov 1;96(6):507-13. — View Citation

Chua TC, Yan TD, Saxena A, Morris DL. Should the treatment of peritoneal carcinomatosis by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy still be regarded as a highly morbid procedure?: a systematic review of morbidity and mortality. Ann Surg. 2009 Jun;249(6):900-7. doi: 10.1097/SLA.0b013e3181a45d86. Review. — View Citation

Klein HJ, Csordas A, Falk V, Slankamenac K, Rudiger A, Schönrath F, Rodriguez Cetina Biefer H, Starck CT, Graf R. Pancreatic stone protein predicts postoperative infection in cardiac surgery patients irrespective of cardiopulmonary bypass or surgical technique. PLoS One. 2015 Mar 20;10(3):e0120276. doi: 10.1371/journal.pone.0120276. eCollection 2015. — View Citation

Lehmann K, Eshmuminov D, Slankamenac K, Kranzbühler B, Clavien PA, Vonlanthen R, Gertsch P. Where Oncologic and Surgical Complication Scoring Systems Collide: Time for a New Consensus for CRS/HIPEC. World J Surg. 2016 May;40(5):1075-81. doi: 10.1007/s0026 — View Citation

Roviello F, Caruso S, Marrelli D, Pedrazzani C, Neri A, De Stefano A, Pinto E. Treatment of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: state of the art and future developments. Surg Oncol. 2011 Mar;20(1):e38-54. doi: 10.1016/j.suronc.2010.09.002. Epub 2010 Dec 15. Review. — View Citation

Sonnenberg EM, Reinke CE, Bartlett EK, Collier KT, Karakousis GC, Holena DN, Kelz RR. Wind, water, wound, walk--do the data deliver the dictum? J Surg Educ. 2015 Jan-Feb;72(1):164-9. doi: 10.1016/j.jsurg.2014.05.019. Epub 2014 Aug 12. — View Citation

Votanopoulos K, Ihemelandu C, Shen P, Stewart J, Russell G, Levine EA. A comparison of hematologic toxicity profiles after heated intraperitoneal chemotherapy with oxaliplatin and mitomycin C. J Surg Res. 2013 Jan;179(1):e133-9. doi: 10.1016/j.jss.2012.01.015. Epub 2012 Mar 10. — View Citation

Younan R, Kusamura S, Baratti D, Cloutier AS, Deraco M. Morbidity, toxicity, and mortality classification systems in the local regional treatment of peritoneal surface malignancy. J Surg Oncol. 2008 Sep 15;98(4):253-7. doi: 10.1002/jso.21057. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C reactive protein (CRP) mg/l, receiver operating characteristic (ROC)		30 days