Evidence map›Paper›PMID 27196482›Full record

Trial reportMedicine2016

Risk Factors for Esophageal Fistula Associated With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Cancer: A Supplementary Analysis of JCOG0303.

Takahiro Tsushima, Junki Mizusawa, Kazuki Sudo, Yoshitaka Honma, Ken Kato, Hiroyasu Igaki, Yasuhiro Tsubosa, Masayuki Shinoda, Kenichi Nakamura, Haruhiko Fukuda and 2 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

47 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Esophageal cancer practice guidelines 2017 edited by the Japan Esophageal Society: part 1.Esophagus : official journal of the Japan Esophageal Society · 2019
    Guideline
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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

12 authors.

Takahiro TsushimaFrom the Division of Gastrointestinal Oncology (TT) and Division of Esophageal Surgery (YT), Shizuoka Cancer Center, Sunto-gun, Shizuoka; JCOG Data Center/Operation Office, National Cancer Center (JM, KN, HF); Gastrointestinal Medical Oncology Division (KS, YH, KK) and Division of Esophageal Surgery (HI), National Cancer Center Hospital; Department of Thoracic Surgery, Aichi Cancer Center (MS); and Department of Surgery, Keio University School of Medicine (YK) Japan.
Junki Mizusawa
Kazuki Sudo
Yoshitaka Honma
Ken Kato
Hiroyasu Igaki
Yasuhiro Tsubosa
Masayuki Shinoda
Kenichi Nakamura
Haruhiko Fukuda
Yuko Kitagawa
Japan Esophageal Oncology Group of Japan Clinical Oncology Group (JCOG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Esophageal fistula is a critical adverse event in patients treated with chemoradiotherapy (CRT) for locally advanced esophageal cancer. However, risk factors associated with esophageal fistula formation in patients receiving CRT have not yet been elucidated.We retrospectively analyzed data obtained from 140 patients who were enrolled in a phase II/III trial comparing low-dose cisplatin with standard-dose cisplatin administered in combination with 5-flurouracil and concomitant radiotherapy. Inclusion criteria were performance status (PS) 0 to 2 and histologically proven thoracic esophageal cancer clinically diagnosed as T4 and/or unresectable lymph node metastasis for which definitive CRT was applicable. Risk factors for esophageal fistula were examined with univariate analysis using Fisher exact test and multivariate analysis using logistic regression models.Esophageal fistula was observed in 31 patients (22%). Of these, 6 patients developed fistula during CRT. Median time interval between the date of CRT initiation and that of fistula diagnosis was 100 days (inter quartile range, 45-171). Esophageal stenosis was the only significant risk factor for esophageal fistula formation both in univariate (P = 0.026) and in multivariate analyses (odds ratio, 2.59; 95% confidence interval, 1.13-5.92, P = 0.025). Other clinicopathological factors, namely treatment arm, age, sex, PS, primary tumor location, T stage, lymph node invasion to adjacent organs, blood cell count, albumin level, and body mass index, were not risk factors fistula formation.Esophageal stenosis was a significant risk factor for esophageal fistula formation in patients treated with CRT for unresectable locally advanced thoracic esophageal squamous cell carcinoma.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemoradiotherapyCisplatinEsophageal FistulaEsophageal NeoplasmsEsophageal StenosisFemaleFluorouracilHumansMaleMiddle AgedRadiotherapyRetrospective StudiesCisplatinFluorouracil

Identifiers

PMID27196482
PMCPMC4902424

What OpenQuestion holds

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LicenceCC BY-ND
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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.