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Characteristics and publication status of gastrointestinal endoscopy clinical trials registered in ClinicalTrials.gov

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Abstract

Background and aims

This study aimed to examine the fundamental characteristics of gastrointestinal (GI) endoscopy trials and evaluate their publication status.

Methods

A cross-sectional analysis was performed in the ClinicalTrials.gov database, and then the PubMed, Medline, Google Scholar, and Embase databases were searched. A dataset containing GI endoscopy clinical studies from ClinicalTrials.gov registered until November 24, 2017, was downloaded. Data of observational and interventional studies were extracted and analyzed. Publications in peer-reviewed journals were examined for completed trials, and factors associated with publication were identified.

Results

A total of 1338 of 253,777 clinical trials were assigned into GI endoscopy, of which 1018 were interventional and 320 were observational studies. Of all the trials, those from the USA comprised the largest percentage (n = 377, 28.18%). The most common field for registered trials was gastroscopy (n = 436, 32.6%), followed by colonoscopy (n = 215, 16.1%), endoscopic ultrasound (n = 186, 13.9%), endoscopic retrograde cholangiopancreatography (n = 176, 13.1%), and novel endoscopic procedure (n = 103, 7.7%). A total of 501 trials were completed before November 25, 2015, 281 (56.1%) of which were published. The median time from study completion to publication was 21 months (interquartile range, 12–32 months). Trials that were comprised of medium sample sizes (150–1000 subjects), conducted in Europe or Asia and other countries, and single or quadruple blinded were more likely to be published.

Conclusions

GI endoscopy is rapidly evolving in clinical applications. Most clinical trials in GI endoscopy are published promptly. These findings demonstrated that investigators are active in performing and communicating the results of clinical trials in the field of GI endoscopy. In the future, the sample size calculation should be presented in detail in the registration system to maintain trial reporting transparency.

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Funding

This study is an independent research funded by the following grants: Medical Science and Technology Plan Projects of Zhejiang Province (No. 2017196257), Youth Foundation of Southwest Medical University (No. 0903-00031099), Doctoral Research Start-up Funding Project of Affiliated Hospital of Southwest Medical University (No. 16229), and Cooperation Project of Southwest Medical University and Luzhou Government (No. 2019LZXNYDJ24).

Author information

Author notes

  1. Shali Tan, Yusha Chen and Li Dai contributed equally to this study.

Authors and Affiliations

  1. Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Street Taiping No. 25, Region Jiangyang, Luzhou, 646099, Sichuan Province, China

    Shali Tan, Yusha Chen, Li Dai, Chunyu Zhong, Jin Xu, Yan Peng & Xiaowei Tang

  2. Department of Gastroenterology, the First Medical Center of Chinese, PLA General Hospital, Beijing, China

    Ningli Chai, Enqiang Linghu & Xiaowei Tang

  3. Department of Gastroenterology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China

    Xujuan Luo & Xiangsheng Fu

Authors
  1. Shali Tan
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  2. Yusha Chen
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  3. Li Dai
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  4. Chunyu Zhong
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  7. Jin Xu
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  8. Xiangsheng Fu
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  9. Yan Peng
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  10. Enqiang Linghu
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  11. Xiaowei Tang
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Contributions

XT, NC, and EL involved in conception and design; YC, LD, and XL participated in analysis and interpretation of the data; ST and CZ drafted the article; YP, XT, and JX contributed to critical revision of the article for important intellectual content ; XF, YP, and XT involved in final approval of the article.

Corresponding author

Correspondence to Xiaowei Tang.

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Disclosures

Shali Tan, Yusha Chen, Li Dai, Chunyu Zhong, Ningli Chai, Xujuan Luo, Jin Xu, Xiangsheng Fu, Yan Peng, Enqiang Linghu, and Xiaowei Tang declared that they have no conflicts of interest or financial ties to disclose.

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Tan, S., Chen, Y., Dai, L. et al. Characteristics and publication status of gastrointestinal endoscopy clinical trials registered in ClinicalTrials.gov. Surg Endosc 35, 3421–3429 (2021). https://doi.org/10.1007/s00464-020-07786-z

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