Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD

NCT05380791 | Recruiting DMC

• 1 other identifier: 2022-SDU-QILU-008
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

rapid swallow (MRS) can assess the contractile reserve capacity of the oesophageal body and identify and diagnose oesophageal motility disorders, but the impact of preoperative oesophageal reserve capacity on postoperative symptoms and motility in patients with GERD remains unclear. The aim of this study was to assess the effect of pre-operative oesophageal reserve capacity on post-reflux symptoms and motility in patients with GERD by using a high-resolution oesophageal manometry-based provocation test, MRS, to track pre-operative ineffective oesophageal motility (IEM).

Conditions

Esophageal Motility Disorders

Keywords

contraction reserve

Outcome Measures

Primary Outcomes (1)

• Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery

  Using high resolution manometry to assess changes in oesophageal motility after anti-reflux surgery, compared to pre-surgery.

  2 year follow-up after anti-reflux surgery

Secondary Outcomes (1)

• Effect of changes of post-anti-reflux surgery symptoms

  2 year follow-up after anti-reflux surgery

Study Arms (2)

IEM in patients with GERD with normal MRS contraction

Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

Other: Follow-up visits

IEM in patients with GERD with abnormal MRS contraction

Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

Other: Follow-up visits

Interventions

Follow-up visits OTHER

Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations

Also known as: Questionnaire to assess symptoms and quality of life etc.

IEM in patients with GERD with abnormal MRS contraction; IEM in patients with GERD with normal MRS contraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients to be treated surgically for gastroesophageal reflux disease. Ineffective esophageal motility diagnosed by high resolution esophageal according to Chicago Classification version 4.0(defined as ≥ 70% of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 50% of swallows with failed peristalsis Performance.

You may qualify if:

• Age over 18 years old
• Patients to be treated surgically for gastroesophageal reflux disease
• Ineffective esophageal motility diagnosed by high resolution esophageal manometry according to Chicago Classification version 4.0
• Obtaining Informed Consent

You may not qualify if:

• Previous other upper gastrointestinal surgery
• Pregnant women and other people with contraindications to surgery and tests
• Other specifically defined esophageal motility disorders, such as nutcracker esophagus

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yanqing Li, phD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

FeiXue Chen, MD

CONTACT

18560086108; qlxhkqz@163.com

Yanqing Li, phD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-President

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 19, 2022
• Study Start: April 22, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

CN (1)