NCT02878668

Brief Summary

Post operative complication after hepatopancreatobiliary surgery is high as 30-50%，which is the main reason for patient admitted to ICU. Several biomarkers have been shown to be useful in the early diagnosis of sepsis and systemic bacterial infection. The purpose of this study is to assess the predictive value of biomarkers for early complication after hepatopancreatobiliary surgery and assess the effectiveness of anti-infectious therapy.

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
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

7 active sites

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

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 22, 2016

Last Update Submit

August 24, 2016

Conditions

Post-operative Complication

Keywords

procalcitoninpost-operativecomplicationCRP

Outcome Measures

Primary Outcomes (1)

  • post operative complication

    within the first 30 days after he operation

Secondary Outcomes (1)

  • sepsis

    within the first 30 days after he operation

Interventions

hepatopancreatobiliary surgeryPROCEDURE

hepatopancreatobiliary surgery

Eligibility Criteria

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

1000 elective hepatopancreatobiliary sugery hospitalized patients will be included

You may qualify if:

  • age \> = 18 years
  • Hospitalized patients with elective hepatopancreatobiliary surgery

You may not qualify if:

  • age \<18 years
  • emergency operative patients
  • Preoperative fever, white blood cell elevation and preoperative infection
  • Systemic inflammatory disease
  • renal failure
  • hematology disease
  • preoperative abnormal PCT, IL-6, IL-8, CRP
  • Laparoscopic cholecystectomy
  • Bile duct infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Friendship hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

The first affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (10)

  • Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.

    PMID: 8094770BACKGROUND

  • Mofidi R, Suttie SA, Patil PV, Ogston S, Parks RW. The value of procalcitonin at predicting the severity of acute pancreatitis and development of infected pancreatic necrosis: systematic review. Surgery. 2009 Jul;146(1):72-81. doi: 10.1016/j.surg.2009.02.013. Epub 2009 May 8.

    PMID: 19541012BACKGROUND

  • Rau BM, Frigerio I, Buchler MW, Wegscheider K, Bassi C, Puolakkainen PA, Beger HG, Schilling MK. Evaluation of procalcitonin for predicting septic multiorgan failure and overall prognosis in secondary peritonitis: a prospective, international multicenter study. Arch Surg. 2007 Feb;142(2):134-42. doi: 10.1001/archsurg.142.2.134.

    PMID: 17309964BACKGROUND

  • Novotny AR, Emmanuel K, Hueser N, Knebel C, Kriner M, Ulm K, Bartels H, Siewert JR, Holzmann B. Procalcitonin ratio indicates successful surgical treatment of abdominal sepsis. Surgery. 2009 Jan;145(1):20-6. doi: 10.1016/j.surg.2008.08.009. Epub 2008 Sep 26.

    PMID: 19081471BACKGROUND

  • Limper M, de Kruif MD, Duits AJ, Brandjes DP, van Gorp EC. The diagnostic role of procalcitonin and other biomarkers in discriminating infectious from non-infectious fever. J Infect. 2010 Jun;60(6):409-16. doi: 10.1016/j.jinf.2010.03.016. Epub 2010 Mar 27.

    PMID: 20347867BACKGROUND

  • Tavares E, Maldonado R, Ojeda ML, Minano FJ. Circulating inflammatory mediators during start of fever in differential diagnosis of gram-negative and gram-positive infections in leukopenic rats. Clin Diagn Lab Immunol. 2005 Sep;12(9):1085-93. doi: 10.1128/CDLI.12.9.1085-1093.2005.

    PMID: 16148175BACKGROUND

  • Scapini P, Lapinet-Vera JA, Gasperini S, Calzetti F, Bazzoni F, Cassatella MA. The neutrophil as a cellular source of chemokines. Immunol Rev. 2000 Oct;177:195-203. doi: 10.1034/j.1600-065x.2000.17706.x.

    PMID: 11138776BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

  • DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9. doi: 10.1097/01.sla.0000246856.03918.9a.

    PMID: 17122618BACKGROUND

  • Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.

    PMID: 16003309BACKGROUND

Study Officials

  • Wenhui Lou, MD

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhui Lou, MD

CONTACT

021-64041990wenhuilou@aliyun.com

Wenchuan Wu, MD

CONTACT

021-64041990wu.wenchuan@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

CN(7)