Evidence map›Paper›PMID 32611448›Full record

ArticleTrials2020

Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial).

Yang Yang, Yuchen Su, Xiaobin Zhang, Jun Liu, Hong Zhang, Bin Li, Rong Hua, Lijie Tan, Hezhong Chen, Zhigang Li

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04135664 (Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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.

NCT04135664 phase3recruitingnot on this map

Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial

TypeinterventionalSponsorShanghai Chest HospitalRan2019 to 2027Enrolled176ConditionsEsophageal CancerArmsesophagectomy, chemoradiation, active surveillance
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Treatment strategy for early-stage esophageal cancer.Japanese journal of radiology · 2024
    Review
  7. Review
  8. Article
  9. 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

10 authors at 4 institutions in 1 country.

Yang YangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Yuchen SuDepartment of Endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Xiaobin ZhangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Jun LiuDepartment of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Hong ZhangDepartment of Endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Bin LiDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Rong HuaDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Lijie TanDepartment of Thoracic Surgery, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China.
Hezhong ChenDepartment of Thoracic Surgery, Changhai Hospital, Naval Military Medical University, No. 168 Changhai Road, Shanghai, 200433, China.
Zhigang LiDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China. zhigang_li_sch@163.com.
Shanghai Jiao Tong University · CNShanghai Chest Hospital · CNFudan University · CNSecond Military Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEsophagectomy is still advised as an additional treatment for pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER). ER followed with definitive chemoradiotherapy (dCRT) has shown increased quality of life as well as comparable oncological outcomes to esophagectomy. However, there is no well-designed phase III trial to compare the two treatments for patients with pT1b ESCC.

methodsOne hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers and randomly assigned to the esophagectomy group or the dCRT group. The clinical lymph node status will be measured by image examination, including computer tomography and positron emission tomography-computed tomography. The pathological tumor status will be diagnosed after endoscopic submucosal dissection (ESD). All patients will be followed up for 60 months after randomization. The primary endpoint is 5-year overall survival. The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates. DISCUSSION: To the best of our knowledge, this is the first phase III randomized controlled trial to compare esophagectomy and dCRT for patients with cN0-pT1b ESCC after ESD. Based on the results of this study, we will show whether dCRT will benefit patients more than esophagectomy, which will contribute more high-quality evidence to the primary salvage treatment for these patients.

trial registrationClinicalTrials.gov, NCT04135664 . Registered on Aug. 10, 2019.

Indexed as

ChemoradiotherapyChinaClinical Trials, Phase III as TopicEndoscopic Mucosal ResectionEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaEsophagectomyHumansMulticenter Studies as TopicNeoplasm Recurrence, LocalNeoplasm StagingRandomized Controlled Trials as TopicSurvival RateTreatment OutcomeDefinitive chemoradiotherapyEndoscopic submucosal dissectionEsophageal cancerEsophagectomyRandomized controlled trialSubmucosal lesion

Identifiers

PMID32611448
PMCPMC7331187
OpenAlexW3040482528

What OpenQuestion holds

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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.