Evidence map›Paper›PMID 30081854›Full record

Trial reportBMC cancer2018

RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer - the S.U.R.G.U.V.A.N.T. trial.

H Paul Redmond, Peter M Neary, Marcel Jinih, Emer O'Connell, Niamh Foley, Rolf W Pfirrmann, Jiang H Wang, D Peter O'Leary

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

H Paul RedmondSurguvant Research Centre, Cork University Hospital, Cork, Ireland.
Peter M NearySurguvant Research Centre, Cork University Hospital, Cork, Ireland.
Marcel JinihSurguvant Research Centre, Cork University Hospital, Cork, Ireland.
Emer O'ConnellSurguvant Research Centre, Cork University Hospital, Cork, Ireland.
Niamh FoleySurguvant Research Centre, Cork University Hospital, Cork, Ireland.
Rolf W PfirrmannSurguvant Research Centre, Cork University Hospital, Cork, Ireland.
Jiang H WangSurguvant Research Centre, Cork University Hospital, Cork, Ireland.
D Peter O'LearySurguvant Research Centre, Cork University Hospital, Cork, Ireland. donaloleary@rcsi.ie.ORCID http://orcid.org/0000-0003-3701-4249
Cork University Hospital · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeri-operative inflammation has been extensively highlighted in cancer patients as detrimental. Treatment strategies to improve survival for cancer patients through targeting peri-operative inflammation have yet to be devised.

methodsWe conducted a multi-centre, randomised controlled clinical trial using Taurolidine in non-metastatic colon cancer patients. Patients were randomly assigned to receive Taurolidine or a placebo. The primary endpoint for the study was the mean difference in day 1 IL-6 levels. Secondary clinical endpoints included rates of post-operative infections and tumor recurrence.

resultsA total of 293 patients were screened for trial inclusion. Sixty patients were randomised. Twenty-eight patients were randomised to placebo and 32 patients to Taurolidine. IL-6 levels were equivalent on day 1 post-operatively in both groups. However, IL-6 levels were significantly attenuated over the 7 day study period in the Taurolidine group compared to placebo (p = 0.04). In addition, IL-6 levels were significantly lower at day 7 in the Taurolidine group (p = 0.04). There were 2 recurrences in the placebo group at 2 years and 1 in the Taurolidine group. The median time to recurrence was 19 months in the Placebo group and 38 months in the Taurolidine group (p = 0.27). Surgical site infection was reduced in the Taurolidine treated group (p = 0.09).

conclusionPeri-operative use of Taurolidine significantly attenuated circulating IL-6 levels in the initial 7 day post-operative period in a safe manner. Future studies are required to establish the impact of IL-6 attenuation on survival outcomes in colon cancer.

trial registrationThe trial was registered with EudraCT (year = 2008, registration number =  005570-12 ) and ISRCTN (year = 2008, registration number =  77,829,558 ).

Indexed as

ColectomyAgedAnti-Inflammatory AgentsAntineoplastic AgentsBiomarkersChemotherapy, AdjuvantColonic NeoplasmsFemaleHumansInflammationInflammation MediatorsInterleukin-6IrelandMaleMiddle AgedNeoplasm Recurrence, LocalAnti-Inflammatory AgentsAntineoplastic AgentsBiomarkersIL6 protein, humanInflammation MediatorsInterleukin-6TaurinetaurolidineThiadiazinesColon cancerInflammationMetastasisPeri-operativeRecurrence

Identifiers

PMID30081854
PMCPMC6091184
OpenAlexW2886151348

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.