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Post-operative ComplicationNCT02878668

The Value of Infectious Biomarkers for Prediction of Complication After Hepatopancreatobiliary Surgery

An observational study of Post-operative Complication, run by Shanghai Zhongshan Hospital at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-operative Complication
What is being tested?
hepatopancreatobiliary surgery
Type of treatment
Surgery or procedure
How many people
700 participants
Where
7 sitesChina
Study dates
Apr 2016to Dec 2017
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: 1000 elective hepatopancreatobiliary sugery hospitalized patients will be included

Who may be able to join

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

Who cannot join

  • age <18 years
  • emergency operative patients
  • Preoperative fever, white blood cell elevation and preoperative infection
  • Systemic inflammatory disease
  • renal failure
  • hematology disease
Show all 9Show fewer
  • preoperative abnormal PCT, IL-6, IL-8, CRP
  • Laparoscopic cholecystectomy
  • Bile duct infection

Trial locations and contacts

7 sites in 1 country.

Wenhui Lou, MD contact

021-64041990 ext. 3450

wenhuilou@aliyun.com

Wenchuan Wu, MD contact

021-64041990 ext. 2909

wu.wenchuan@zs-hospital.sh.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Beijing Friendship hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Zhongtao Zhang, MD

    Zhongtao Zhang, MD

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Xubao Liu, MD

    Xubao Liu, MD

    Recruiting

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

    Guangzhou, Guangdong, 510120

    Yajin Chen, MD

    Yajin Chen, MD

    Not yet recruiting

  • The first affiliated hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Bei Sun, MD

    Bei Sun, MD

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Kuirong Jiang, MD

    Kuirong Jiang, MD

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Wenhui Lou, MD, 021-64041990 ext. 3450, wenhuilou@aliyun.com

    Wenchuan Wu, MD, 021-64041990 ext. 2909, wu.wenchuan@zs-hospital.sh.cn

    Recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Gang Jin, MD

    Gang Jin, MD

    Recruiting

Other trials in China

About this study

Official title: The Predictor of Infectious Complication After Hepatopancreatobiliary Surgery and Monitoring Indicator of Anti-infectious Therapy

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.

Read the detailed description

Postoperative complication after major abdominal surgery, such as pancreatic surgery and hilar cholangiocarcinoma surgery, is higher, up to 30 to 50%.It is the mainly reason for the patient to admit to ICU. Among this, the most common and difficult to handle complication is mainly anastomotic fistula, abdominal effusion and subsequent secondary infection. Delayed diagnosis can cause systemic inflammatory response syndrome (SIRS), multiple organ failure ( MODS), and even death. From a surgical point of view, it leads to surgical failure and often need the second surgery. However, the diagnosis and treatment of postoperative infection is also facing two problems: it is difficult to confirm the diagnosis and make treatment decision. Hence, there is a strong need of an additional tool to early diagnose post operative complication.

Serum procalcitonin (PCT), is a 116 amino-acids protein produced by C-cells of the thyroid gland. PCT baseline levels are low (<0.05 ng/ml), but increase significantly in patients with severe bacterial infections. Therefore, PCT levels are used to monitor the course and prognosis of systemic bacterial infections and to tailor the therapeutic interventions more efficiently. Furthermore, PCT could serve as an early predictive marker for the clinical course of septic complications after abdominal surgery. The aim of this study is to demonstrate if PCT is a more sensible, specific and reliable biomarker of post operative complication than other biomarkers

The investigators conducted a observational, prospective study. All patients undergoing electively hepatopancreatobiliary surgery in seven centres are recruited. In all cases white blood count (WBC), C-reactive protein (CRP) and PCT levels are measured in 1st, 3rd and 5th postoperative day (POD). Informed consent was obtained in all patients.The study is approved by the hospital's Ethical Committee.

Being tested
hepatopancreatobiliary surgery
Keywords
procalcitonin, post-operative, complication, CRP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hepatopancreatobiliary surgeryProcedure or surgery

    hepatopancreatobiliary surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. post operative complication

    Measured: within the first 30 days after he operation

Secondary outcomes (1)

  1. sepsis

    Measured: within the first 30 days after he operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02878668
Sponsor's protocol ID
ZS-LWH-2016
Status last verified
Aug 2016
First submitted
22 Aug 2016
Last updated
25 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 8094770

  • 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.

    PubMed 19541012

  • 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.

    PubMed 17309964

  • 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.

    PubMed 19081471

  • 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.

    PubMed 20347867

  • 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.

    PubMed 16148175

  • 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.

    PubMed 11138776

  • 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.

    PubMed 15273542

  • 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.

    PubMed 17122618

  • 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.

    PubMed 16003309

Questions about this trial

What is this clinical trial studying?

An observational study of Post-operative Complication, run by Shanghai Zhongshan Hospital at 7 sites in China.

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 2 inclusion and 9 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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 Wenhui Lou, MD (021-64041990 ext. 3450, wenhuilou@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post operative complication (time frame: within the first 30 days after he operation). 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 NCT02878668, which also lists 10 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 25 Aug 2016.

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