Evidence map›Paper›PMID 37337238›Full record

ArticleTrials2023

PYloroplasty versus No Intervention in GAstric REmnant REconstruction after Oesophagectomy: study protocol for the PYNI-GAREREO phase III randomized controlled trial.

Naoya Okada, Yoshihiro Kinoshita, Shoji Nishihara, Takuma Kurotaki, Aya Sato, Kotaro Kimura, Hiroki Kushiya, Kazufumi Umemoto, Shotaro Furukawa, Takumi Yamabuki and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. 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
0.6field-weighted citation impact, top 31% 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.

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, 2 citations in OpenAlex.

  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

14 authors at 1 institution in 1 country.

Naoya OkadaDepartment of Surgery and Center of Esophageal Diseases, Teine Keijinkai Hospital, 1-40 Maeda, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan. okada-na@keijinkai.or.jp.ORCID http://orcid.org/0000-0002-1443-9191
Yoshihiro KinoshitaDepartment of Surgery and Center of Esophageal Diseases, Teine Keijinkai Hospital, 1-40 Maeda, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan. yoshihirokinoshita@nifty.com.
Shoji NishiharaDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Takuma KurotakiDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Aya SatoDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Kotaro KimuraDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Hiroki KushiyaDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Kazufumi UmemotoDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Shotaro FurukawaDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Takumi YamabukiDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Minoru TakadaDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Kentaro KatoDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Yoshiyasu AmboDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Fumitaka NakamuraDepartment of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido, 006-8555, Japan.
Teine Keijinkai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAfter esophagectomy for esophageal and esophagogastric cancer, more than half of patients have lost > 10% of their body weight at 12 months. In most cases, the gastric remnant is used for reconstruction after esophagectomy. One of the most serious nutritional complications of this technique is delayed gastric emptying caused by gastric remnant mobilization and denervation of the vagus nerve. The aim of the PYloroplasty versus No Intervention in GAstric REmnant REconstruction after Oesophagectomy (PYNI-GAREREO) trial is to analyze the clinical outcome of modified Horsley pyloroplasty (mH-P) as a method of preventing delayed gastric emptying.

methodsThe PYNI-GAREREO trial is designed as an open randomized, single-center superiority trial. Patients will be randomly allocated to undergo gastric remnant reconstruction with mH-P (intervention group) or no intervention (control group) in parallel groups. All patients with esophageal cancer or esophagogastric cancer planning to undergo curative minimally invasive esophagectomy will be considered for inclusion. A total of 140 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is the body weight change at 6 months postoperatively, and the secondary outcomes are the nutritional status, postoperative complications, functional outcome, and quality of life until 1 year postoperatively. DISCUSSION: We hypothesize that mH-P after minimally invasive esophagectomy more effectively maintains patients' nutritional status than no pyloroplasty.

trial registrationUMIN Clinical Trials Registry UMIN000045104. Registered on 25 August 2021. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051346 .

Indexed as

Esophageal NeoplasmsGastric StumpGastroparesisStomach NeoplasmsBody WeightEquivalence Trials as TopicEsophagectomyHumansQuality of LifeRandomized Controlled Trials as TopicEsophageal cancerEsophagectomyEsophagogastric cancerGastric reconstructionGastric remnantNutritionPyloroplastyQuality of lifeRandomized controlled trial

Identifiers

PMID37337238
PMCPMC10278249
OpenAlexW4381149166

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.