Evidence map›Paper›PMID 31226960›Full record

ArticleBMC cancer2019

Robot-assisted esophagectomy (RAE) versus conventional minimally invasive esophagectomy (MIE) for resectable esophageal squamous cell carcinoma: protocol for a multicenter prospective randomized controlled trial (RAMIE trial, robot-assisted minimally invasive Esophagectomy).

Yang Yang, Xiaobin Zhang, Bin Li, Zhigang Li, Yifeng Sun, Teng Mao, Rong Hua, Yu Yang, Xufeng Guo, Yi He and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03094351 (Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 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.

NCT03094351 phase3unknown statusnot on this map

Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)

TypeinterventionalSponsorShanghai Chest HospitalRan2017 to 2024Enrolled360ConditionsEsophageal Cancer, Esophageal CarcinomaArmsesophagectomy
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  5. Article
  6. Article
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  8. Article
  9. Review
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  12. A safe and effective anastomotic technique for robot-assisted minimally invasive oesophagectomy: Reverse-puncture anastomosis.The international journal of medical robotics + computer assisted surgery : MRCAS · 2022
    Article
  13. Article
  14. Health-related quality of life after esophagectomy in patients with esophageal cancer.Esophagus : official journal of the Japan Esophageal Society · 2022
    Review
  15. Review
  16. Article
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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

13 authors.

Yang YangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Xiaobin ZhangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Bin LiDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Zhigang LiDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China. dr_lizhigang@163.com.ORCID http://orcid.org/0000-0002-2540-8032
Yifeng SunDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Teng MaoDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Rong HuaDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Yu YangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Xufeng GuoDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Yi HeDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No. 241, Huaihai West Rd, Shanghai, 200030, China.
Hecheng LiDepartment of Thoracic Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Rd, Shanghai, 200025, China.
Hezhong ChenDepartment of Thoracic Surgery, Changhai Hospital Affiliated to The Second Military Medical University, No. 168, Changhai Rd, Shanghai, 200433, China.
Lijie TanDepartment of Thoracic Surgery, Zhongshan Hospital Affiliated to Fudan University, No. 180, Fenglin Rd, Shanghai, 200032, China.

Funding

Shanghai Hospital Development Center 16CR1035B
6 · The paper itself

Abstract

backgroundCurrently, there are three main surgical approaches for resectable esophageal cancer: open transthoracic esophagectomy (OTE), conventional minimally invasive esophagectomy (MIE) and robot-assisted esophagectomy (RAE). Previous studies had demonstrated the better short-term outcomes in MIE or RAE when compared to OTE, respectively. However, to date, no prospective study was designed to compare these two minimally invasive approaches (MIE and RAE). The primary objective of this study is to compare the outcomes on survival, safety and efficacy, quality of life between RAE and MIE in the treatment for resectable esophageal squamous cell carcinoma (ESCC).

methodsThis study is designed as a multicenter, prospective, randomized, non-inferiority phase III clinical trial, investigating the safety and efficacy of RAE compared with MIE in the treatment of resectable ESCC. Eligible patients are randomly assigned to either RAE (n = 180) or MIE (n = 180) group. The follow-up visits will be scheduled at 3, 6, 9, and 12 months in the first two years, and then every 6 months until the end of the study. During the follow-up period, clinical data and quality of life questionnaires will be examined. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are 3-year OS, 5-year disease-free survival (DFS), short-term outcomes as well as quality of life. DISCUSSION: This is the first prospectively randomized controlled trial designed to compare RAE with MIE as surgical treatment for resectable ESCC. According to our hypothesis, RAE will result in at least similar oncologic outcomes and long-term quality of life, but with a shorter operation time, lower percentage of perioperative complications, lower blood loss, and shorter hospital stay when compared with MIE. This study started in July 2017. Follow-up will terminate after 5 years from the time when the last patient was enrolled.

trial registrationClinicalTrial.gov: NCT03094351 (March 29, 2017). The trial was prospectively registered.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaEsophagectomyMinimally Invasive Surgical ProceduresRobotic Surgical ProceduresAdolescentAdultAgedClinical Trials, Phase III as TopicDisease-Free SurvivalEquivalence Trials as TopicFemaleFollow-Up StudiesHumansLength of StayMaleComplicationsEfficacyQuality of lifeRobot-assisted surgeryThoracoscopic esophagectomy

Identifiers

PMID31226960
PMCPMC6587242

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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.