Evidence map›Paper›PMID 34782599›Full record

Trial reportNature communications2021

Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer.

Jing Guo, Aman Xu, Xiaowei Sun, Xuhui Zhao, Yabin Xia, Huamin Rao, Yaming Zhang, Rupeng Zhang, Li Chen, Tao Zhang and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02745509 (A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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.

NCT02745509 nacompletednot on this map

A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2016 to 2017Enrolled508ConditionsGastric CancerArmsExtensive Intraoperative Peritoneal Lavage
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Integration of Genomic Biology Into Therapeutic Strategies of Gastric Cancer Peritoneal Metastasis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Review
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

13 authors.

Jing Guo *Department of Gastric Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Aman Xu *Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, HeFei, Anhui, China.
Xiaowei Sun *Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
Xuhui Zhao *Department of General Surgery, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital), Hefei, Anhui, China.
Yabin Xia *Department of General Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China.
Huamin Rao *Department of Abdominal Surgery, Jiangxi Provincial Cancer Hospital, Nanchang, Jiangxi, China.
Yaming ZhangDepartment of Surgical Oncology, Anqing Municipal Hospital, Anqing, Anhui, China.
Rupeng ZhangDepartment of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China.
Li ChenDepartment of General Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Tao ZhangDepartment of Gastrointestinal Surgery, Yuebei People's Hospital, Shaoguan, Guangdong, China.
Gang LiDepartment of General Surgery, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China.
Hongtao XuDepartment of General Surgery, Lishui Municipal Central Hospital, Lishui, Zhejiang, China.
Dazhi XuDepartment of Gastric Surgery, Fudan University Shanghai Cancer Center, Shanghai, China. xudzh@shca.org.cn.ORCID 0000-0002-2265-1272

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Whether extensive intraoperative peritoneal lavage (EIPL) after gastrectomy is beneficial to patients with locally advanced gastric cancer (AGC) is not clear. This phase 3, multicenter, parallel-group, prospective randomized study (NCT02745509) recruits patients between April 2016 and November 2017. Eligible patients who had been histologically proven AGC with T3/4NxM0 stage are randomly assigned (1:1) to either surgery alone or surgery plus EIPL. The results of the two groups are analyzed in the intent-to-treat population. A total of 662 patients with AGC (329 patients in the surgery alone group, and 333 in the surgery plus EIPL group) are included in the study. The primary endpoint is 3-year overall survival (OS). The secondary endpoints include 3-year disease free survival (DFS), 3-year peritoneal recurrence-free survival (reported in this manuscript) and 30-day postoperative complication and mortality (previously reported). The trial meets pre-specified endpoints. Estimated 3-year OS rates are 68.5% in the surgery alone group and 70.6% in the surgery plus EIPL group (log-rank p = 0.77). 3-year DFS rates are 61.2% in the surgery alone group and 66.0% in the surgery plus EIPL group (log-rank p = 0.24). The pattern of disease recurrence is similar in the two groups. In conclusion, EIPL does not improve the 3-year survival rate in AGC patients.

Indexed as

AgedDisease-Free SurvivalFemaleGastrectomyHumansMaleMiddle AgedNeoplasms, Second PrimaryPeritoneal LavageProspective StudiesStomachStomach NeoplasmsSurgical OncologySurvival Rate

Identifiers

PMID34782599
PMCPMC8594430

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Registered trials

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.