Evidence map›Paper›PMID 30445943›Full record

Trial reportBMC cancer2018

Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial.

Ziyu Li, Fei Shan, Xiangji Ying, Kan Xue, Jiafu Ji

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 trial NCT03564834 (Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 29% 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.

NCT03564834 phase2unknown statusnot on this map

Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients: a Phase II Randomized Parallel Controlled Trial

TypeinterventionalSponsorPeking UniversityRan2018 to 2023Enrolled180ConditionsAdvanced Gastric CancerArmsLaparoscopic gastrectomy, Open gastrectomy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Current clinical trials on gastric cancer surgery in China.World journal of gastrointestinal oncology · 2024
    Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. 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

5 authors at 1 institution in 2 countries.

Ziyu LiKey laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, No.52 Fucheng Road, Haidian District, Beijing, 100142, China.
Fei ShanKey laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, No.52 Fucheng Road, Haidian District, Beijing, 100142, China.
Xiangji YingKey laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, No.52 Fucheng Road, Haidian District, Beijing, 100142, China.
Kan XueKey laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, No.52 Fucheng Road, Haidian District, Beijing, 100142, China.
Jiafu JiKey laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, No.52 Fucheng Road, Haidian District, Beijing, 100142, China. jijiafu@hsc.pku.edu.cn.ORCID http://orcid.org/0000-0002-4235-4507
Peking University · CN

Funding

Beijing Municipal Commission of Health and Family Planning 2018-4-2156
6 · The paper itself

Abstract

backgroundGastric cancer is one of the most common malignant tumors worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer is increasing. Surgery is the essential treatment for local advanced gastric cancer. However, elderly patients are at high risk of postoperative complications due to reduced functional reserve and increased comorbidities. Laparoscopic gastrectomy may be a promising surgery approach for elderly patients but its benefits remain controversial. We therefore proposed this randomized trial to evaluate the safety and efficacy of laparoscopic versus open gastrectomy for local advanced gastric cancer in patients aged 70 and above.

methodsThe current study has a randomized, parallel controlled, single-center, open-label, superiority design with two arms. A sample of 180 local advanced gastric cancer patients aged 70 and above will be recruited in Peking University Cancer Hospital and Institute. Participants will be randomized to either receive open or laparoscopic gastrectomy. The primary outcome is surgical safety, including complication rate, reoperation rate, readmission rate, and mortality rate within 30 days after surgery. The secondary endpoints include postoperative rehabilitation status, one-year postoperative life quality, three-year overall and disease-free survival. Assessments will take place at baseline (before random assignment), at 30 days, one-year, and three-year after the surgery. The study has been approved by an ethical review board. DISCUSSION: We hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above. If this hypothesis is statistically proved, the rational introduction of minimally invasive surgery technique in traditional gastrectomy can help improve the surgical safety for elderly patients, reduce patient financial burden, shorten hospital stay, and improve hospital beds turnover rate. Our research data will also provide high quality clinical evidence and data support for the conduction of multicenter phase III clinical trials.

trial registrationThe study has been prospectively registered in ClinicalTrial.gov ( NCT03564834 ).

Indexed as

AgedDisease-Free SurvivalFemaleGastrectomyHumansLaparoscopyLength of StayMalePostoperative ComplicationsProspective StudiesStomachStomach NeoplasmsTreatment OutcomeEfficacyElderlyGastric cancerLaparoscopic gastrectomyOpen gastrectomySafetySurvival

Identifiers

PMID30445943
PMCPMC6240197
OpenAlexW2901198296

What OpenQuestion holds

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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.