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

Trials · 14 authors, 2 centres

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TL;DR

The trial aims to test if pyloroplasty better preserves patients' nutritional status, with body weight change at 6 months as the primary outcome.

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The primary endpoint is body weight loss at 6 months post-surgery. Secondary endpoints include nutritional status (evaluated via bioimpedance, blood tests), oral intake, pyloric transit (assessed via contrast and endoscopy), postoperative complications, and quality of life (assessed via questionnaires) up to 12 months. Methods include randomization in a 1:1 ratio, with patients blinded to allocation, though surgeons are not. Statistical analysis will use the Mann–Whitney U-test for continuous variables. This is a protocol paper; therefore, no results are reported.

STUDY TYPE

RCT

SPECIALTY

surgery

SUMMARISED BY

AI pipeline

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ORIGINAL PAPER

PMC10278249

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

Trials

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ABSTRACT

Abstract Background After 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. Methods The 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 registration UMIN Clinical Trials Registry UMIN000045104. Registered on 25 August 2021. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051346 . Supplementary Information The online version contains supplementary material available at 10.1186/s13063-023-07435-5. Keywords: Pyloroplasty, Esophageal cancer, Esophagogastric cancer, Esophagectomy, Gastric remnant, Gastric reconstruction, Nutrition, Quality of life, Randomized controlled trial

CITATION EXPORT

Naoya Okada, Yoshihiro Kinoshita, Shoji Nishihara et al.. PYloroplasty versus No Intervention in GAstric REmnant REconstruction after Oesophagectomy: study protocol for the PYNI-GAREREO phase III randomized controlled trial. Trials. (2023). https://doi.org/10.1186/s13063-023-07435-5

AUTHORS

14 · 2 CENTRES

Naoya Okada, Yoshihiro Kinoshita, Shoji Nishihara, Takuma Kurotaki, Aya Sato, Kotaro Kimura, Hiroki Kushiya, Kazufumi Umemoto, Shotaro Furukawa, Takumi Yamabuki, Minoru Takada, Kentaro Kato, Yoshiyasu Ambo, Fumitaka Nakamura

1Department of Surgery and Center of Esophageal Diseases, Teine Keijinkai Hospital, 1-40 Maeda, Teine-Ku, Sapporo, Hokkaido 006-8555 Japan
2Department of Surgery, Teine Keijinkai Hospital, 1-40 Maeda1-12, Teine-Ku, Sapporo, Hokkaido 006-8555 Japan