NCT02741167

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2.9 years

First QC Date

March 30, 2016

Last Update Submit

May 3, 2017

Conditions

Peritoneal Cancer

Keywords

peritoneal surface malignanciescytoreductive surgeryhyperthermic intraperitoneal chemotherapy

Outcome Measures

Primary Outcomes (1)

  • C reactive protein (CRP) mg/l, receiver operating characteristic (ROC)

    30 days

Study Arms (1)

CRS and HIPEC

Patients subjected to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) due to primary or secondary peritoneal malignancy

Procedure: CRS and HIPEC

Interventions

CRS and HIPECPROCEDURE

During CRS, all visible peritoneal tumors are removed. Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy

CRS and HIPEC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive adult patients (more than 18 years) subjected to cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) due to peritoneal malignancy at our institution.

You may qualify if:

  • 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

You may not qualify if:

  • No primary or secondary peritoneal surface malignancy
  • No CRS and HIPEC
  • Pregnancy
  • Younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Visceral Surgery and Transplantation , University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (9)

  • 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.

    PMID: 19474692BACKGROUND

  • 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.

    PMID: 20888755BACKGROUND

  • Klein HJ, Csordas A, Falk V, Slankamenac K, Rudiger A, Schonrath 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.

    PMID: 25793700BACKGROUND

  • 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.

    PMID: 18726887BACKGROUND

  • 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.

    PMID: 22480844BACKGROUND

  • 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.

    PMID: 25131719BACKGROUND

  • Lehmann K, Eshmuminov D, Slankamenac K, Kranzbuhler 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/s00268-015-3366-0.

    PMID: 26669784RESULT

  • 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. doi: 10.1002/jso.20837.

    PMID: 17708508RESULT

  • Roth L, Eshmuminov D, Laminger F, Koppitsch C, Schneider M, Graf TR, Gupta A, Kober F, Roka S, Gertsch P, Lehmann K. Systemic inflammatory response after hyperthermic intraperitoneal chemotherapy (HIPEC): The perfusion protocol matters! Eur J Surg Oncol. 2019 Sep;45(9):1734-1739. doi: 10.1016/j.ejso.2019.03.036. Epub 2019 Mar 29.

    PMID: 30954352DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Kuno Lehmann, Md. PhD

    Dr. Kuno Lehmann, Division of Visceral Surgery and Transplantation, University Hospital Zurich, Ramistrasse 100, 8091 Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuno Lehmann, MD, PhD

CONTACT

+41 44 255 23 04kuno.lehmann@usz.ch

Dilmurodjon Eshmuminov, MD

CONTACT

+41 44 255 11 11dilmurodjon.eshmuminov@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 18, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)