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OpenTrials
Completed

NCT Number: NCT07132476

The Construction and Validation of a Risk Prediction Model for Perioperative Hypoglycemia in Digestive Endoscopy

Digestive endoscopic surgery, including diagnosis and treatment interventions, has become an indispensable means of managing various gastrointestinal diseases in modern gastroenterology practice. Perioperative hypoglycemia is a common but not fully recognized complication. The reported incidence rate of different study populations and types of surgery ranges from 6.75% to 17.50%. The clinical consequences of endoscopic hypoglycemia are profound. Recurrent attacks are associated with an increased risk of transient ischemic attacks and other cardiovascular and cerebrovascular events. From the perspective of the healthcare system, hypoglycemia may reduce patients' compliance with the intake of intestinal cleaning agents, leading to inadequate intestinal preparation, affecting the effectiveness of diagnosis and treatment, prolonging endoscopic surgery time, increasing hospitalization days and costs. This study aims to develop and validate a comprehensive nomogram that integrates three key dimensions: traditional metabolic risk factors (diabetes status, fasting time), program variables (infusion rate, somatostatin use), and new psychosocial factors (anxiety, sleep quality). By using machine learning enhanced logistic regression to prospectively collect data from 610 patients from multiple centers, the resulting column chart model provides clinical doctors with a practical tool for personalized risk stratification and targeted intervention measures, such as reducing anxiety protocols or optimizing fluid management for high-risk patients. The purpose of this study is to identify the influencing factors of hypoglycemia during the perioperative period of digestive endoscopy, help identify and screen high-risk populations, provide theoretical basis for the development of intervention measures, reduce the occurrence of hypoglycemia during the perioperative period of endoscopy, improve patient satisfaction, and reduce hospitalization time and costs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 312000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Endoscopic surgical methods include endoscopic retrograde cholangiopancreatography (ERCP), endoscopic mucosal resection/stripping (endoscopic mucosal resection, EMR/endoscopic submucosal dissection, ESD), high-frequency electroresection or cold resection of polyps, endoscopic hemostasis, and endoscopic ultrasound-guided puncture, etc.; ③ Patients who have given informed consent and voluntarily participate in the survey.

Exclusion criteria

① Those who cannot cooperate with the questionnaire survey;

② Those who cannot cooperate with postoperative diet and fluid management or blood glucose monitoring.

Treatment and study plan

No Adjuvant Therapy

Other

Observe and record hypoglycemia

Primary outcomes

  1. hypoglycemia

    Time frame: perioperative period of the endoscopic

  2. hypoglycemia

    Time frame: the perioperative period of the endoscopic

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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