Evidence map›Paper›PMID 40155976›Full record

ArticleTrials2025

Whole stomach versus narrow gastric tube reconstruction after esophagectomy for esophageal cancer (ATHLETE trial): study protocol for a randomized controlled trial.

Junya Kitadani, Keiji Hayata, Taro Goda, Shinta Tominaga, Naoki Fukuda, Tomoki Nakai, Shotaro Nagano, Toshiyasu Ojima, Toshio Shimokawa, Manabu Kawai

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Junya KitadaniSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan. kitadani@wakayama-med.ac.jp.ORCID http://orcid.org/0000-0002-2150-0253
Keiji HayataSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Taro GodaSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Shinta TominagaSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Naoki FukudaSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Tomoki NakaiSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Shotaro NaganoSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Toshiyasu OjimaSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.
Toshio ShimokawaClinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Manabu KawaiSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, 811-1 Kimiidera, Wakayama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are two types of methods of creating a gastric conduit after esophagectomy for patients with esophageal cancer: narrow gastric tube reconstruction or whole stomach reconstruction. Whole stomach reconstruction with good blood perfusion was reported in a prospective cohort study to be safe and that it has the possibility to prevent anastomotic leakage (AL). We therefore planned a randomized controlled phase III study to investigate the superiority of whole stomach reconstruction over narrow gastric tube reconstruction after esophagectomy for esophageal cancer.

methodsThis is a single center, two-arm, open-label, randomized phase III trial. We calculated that 65 patients in each arm of this study and total study population of 130 patients are required according to our historical data on narrow gastric tube reconstruction and prospective data on whole stomach reconstruction. In the narrow gastric tube group, a 3.5-cm-wide gastric tube is made along the greater curvature of the stomach using linear staplers. Otherwise, in the whole stomach group, after the lymphadenectomy of the lesser curvature and No.2, the stomach is cut just below the esophagogastric junction using a linear stapler. The primary endpoint of this study is the incidence of AL. Secondary endpoints are the occurrence rate of anastomotic stenosis, the occurrence rate of pneumonia, the occurrence rate of all postoperative complications, the occurrence rate of reflux esophagitis, quality of life evaluation by EORTC QLQ-C30 and EORTC OES-18, nutritional evaluation, the amount of blood loss, postoperative hospital stays, and blood flow evaluation. Complications are evaluated using the Clavien-Dindo classification (version 2.0), and those of grade II or higher are considered to be postoperative complications. DISCUSSION: If the optimal method for creating a gastric conduit after esophagectomy is clarified, it may be possible to contribute to improving short-term and long-term surgical outcomes for patients undergoing surgery for esophageal cancer.

trial registrationThe protocol of ATHLETE trial was registered in the UMIN Clinical Trials Registry as UMIN000050677 ( http://www.umin.ac.jp/ctr/index.htm ). Date of registration: March 26, 2023. Date of first participant enrollment: March 27, 2023.

Indexed as

Esophageal NeoplasmsEsophagectomyPlastic Surgery ProceduresStomachAnastomosis, SurgicalAnastomotic LeakClinical Trials, Phase III as TopicEquivalence Trials as TopicHumansLymph Node ExcisionProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeEsophageal cancerEsophagectomyGastric tubeWhole stomach

Identifiers

PMID40155976
PMCPMC11954340

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.