Evidence map›Paper›PMID 30285673›Full record

Trial reportBMC cancer2018

Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02-01 multicenter randomized controlled clinical trial.

Hongyong He, Haojie Li, Xiangqian Su, Ziyu Li, Peiwu Yu, Hua Huang, Changming Huang, Jianxin Ye, Yong Li, Jian Suo and 10 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence 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. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 8% 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.

NCT03007550 nacompletednot on this map

Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Laparoscopic And Open Total Gastrectomy In Patients With Clinical Stage I Gastric Cancer

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2017 to 2018Enrolled227ConditionsGastric CancerArmsLaparoscopic total gastrectomy, Open total gastrectomy
NCT04710758 narecruitingnot on this mapstarted 2021, after this paper: background citation

Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2021 to 2028Enrolled1,018ConditionsStomach NeoplasmsArmsLaparoscopic total gastrectomy, Open total gastrectomy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Current clinical trials on gastric cancer surgery in China.World journal of gastrointestinal oncology · 2024
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. [Reconstruction following gastrectomy].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2021
    Review
  13. Article
  14. Article
  15. Article
  16. Article
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

20 authors at 11 institutions in 1 country.

Hongyong HeDepartment of General Surgery, Zhongshan Hospital, Fudan University, Fenglin Road 180, Shanghai, 200032, China.ORCID http://orcid.org/0000-0001-7371-4133
Haojie LiDepartment of General Surgery, Zhongshan Hospital, Fudan University, Fenglin Road 180, Shanghai, 200032, China.
Xiangqian SuDepartment of General Surgery, Beijing Cancer Hospital, Peking University, Beijing, 100142, China.
Ziyu LiDepartment of General Surgery, Beijing Cancer Hospital, Peking University, Beijing, 100142, China.
Peiwu YuDepartment of General Surgery, Southwest Hospital, Third Military Medical University, Chongqing, 400038, China.
Hua HuangDepartment of General Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Changming HuangDepartment of General Surgery, Fujian Medical University Union Hospital, Fuzhou, 350001, China.
Jianxin YeDepartment of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350009, China.
Yong LiDepartment of General Surgery, Guangdong General Hospital, Guangzhou, 510080, China.
Jian SuoDepartment of General Surgery, The First Bethune Hospital of Jilin University, Changchun, 130021, China.
Jiren YuDepartment of General Surgery, The First Affiliated Hospital, Zhejiang University, Hangzhou, 310003, China.
Guoxin LiDepartment of General Surgery, Nangfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Zekuan XuDepartment of General Surgery, The First Affiliated Hospital With Nanjing Medical University, Nanjing, 210029, China.
Gang ZhaoDepartment of General Surgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, 200240, China.
Hui CaoDepartment of General Surgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, 200240, China.
Jiankun HuDepartment of General Surgery, West China Hospital, Sichuan University, Chengdu, 610041, China.
Xiaohui DuDepartment of General Surgery, Chinese PLA General Hospital, Beijing, 10853, China.
Fenglin LiuDepartment of General Surgery, Zhongshan Hospital, Fudan University, Fenglin Road 180, Shanghai, 200032, China. liu.fenglin@zs-hospital.sh.cn.
Yihong SunDepartment of General Surgery, Zhongshan Hospital, Fudan University, Fenglin Road 180, Shanghai, 200032, China. sun.yihong@zs-hospital.sh.cn.
Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group
Fudan University · CNFujian Medical University · CNArmy Medical University · CNPeking University · CNRenji Hospital · CNSichuan University · CNFirst Affiliated Hospital Zhejiang University · CNFirst Bethune Hospital of Jilin University · CNGuangdong General Hospital · CNSouthern Medical University · CNZhongshan Hospital · CN

Funding

Clinical Trial Fund of Zhongshan Hospital 2016ZSLC13
6 · The paper itself

Abstract

backgroundThe safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02-01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG).

methodsThis CLASS02-01 trial is a prospective, multicenter, randomized, controlled, open, and non-inferiority trial. Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into LTG group (n = 100) and OTG group (n = 100). The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study. DISCUSSION: This CLASS02-01 trial is the first prospective randomized two-arm controlled study to determine the safety of LTG compared with OTG. Through this trial, we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer.

trial registrationClinicalTrials.gov ID: NCT03007550 . December 30, 2016.

Indexed as

GastrectomyLaparoscopyFemaleFollow-Up StudiesHumansMaleNeoplasm StagingPostoperative CarePostoperative ComplicationsStomach NeoplasmsTreatment OutcomeGastric cancerLaparoscopic total gastrectomyRandomized controlled trialSafety

Identifiers

PMID30285673
PMCPMC6171153
OpenAlexW2895681162

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.