A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy

NCT05539105 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Observational

Started

2022-08-22

Last updated

2022-09-14

Condition(s) studied

Proximal Gastric AdenocarcinomaReconstruction

Investigational drug(s) / intervention(s)

Double tract reconstructionGastric conduit reconstructionOther reconstructions

Double tract reconstruction: Double tract reconstruction would be applied after radical proximal gastrectomy.

Gastric conduit reconstruction: Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

Other reconstructions: Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Study summary

This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Aged 18-80 years * Tumor located in the upper or esophagogastric junction (EGJ), and curative resection with more than 1/2 remant is expected to be achievable by proximal gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers); * Clinical stage T1NxM0 (According to AJCC-8th TNM staging system) of the upper stomach or diameter of EGJ cancer less than 4cm with invading esophgus no more than 2cm without any distant metastasis; * Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma; * Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1 * Preoperative ASA (American Society of Anesthesiologists) scoring: I-III * Sufficient organ functions * Written informed consent Exclusion Criteria: \-

Primary outcome measure(s)

Reflux esophagitis incidence 1 year after surgery — 1 year
Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital Fudan University	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05539105 on ClinicalTrials.gov ↗ ← All trials in China