Hot Water Drinking Therapy in Achalasia (AHW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01863966
First received: May 21, 2013
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.


Condition Intervention
Achalasia
Other: hot water drinking therapy
Procedure: Pneumatic dilation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Change from baseline achalasia symptom score at 1 month [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]
    Dysphagia, Regurgitation and Chest Pain scores


Secondary Outcome Measures:
  • Number of patients with adverse effects [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
    adverse effects of drinking water like distention, nausea and belching

  • Change from baseline in barium esophagram at 1 year [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    measure esophageal diameter

  • Endoscopy at 1 year [ Time Frame: year 1 ] [ Designated as safety issue: No ]
    esophageal bezoars and esophageal cancer

  • Pneumatic dilation rate and relative efficacy [ Time Frame: any time ] [ Designated as safety issue: No ]
    Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation

  • Change from baseline in achalasia symptom score at 1 year [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
    Dysphagia,Regurgitation and Chest Pain scores

  • Change from baseline achalasia symptom scores at 5 years [ Time Frame: baseline and 5 years ] [ Designated as safety issue: No ]
    Dysphagia,Regurgitation and Chest Pain scores

  • Change from baseline in barium esophagram at 5 years [ Time Frame: baseline and 5 years ] [ Designated as safety issue: No ]
    measure esophageal diameter

  • Endoscopy at 5 years [ Time Frame: year 5 ] [ Designated as safety issue: No ]
    esophageal bezoars and esophageal cancer


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hot water drinking therapy
Hot water drinking before,after meal and before sleep
Other: hot water drinking therapy
Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep
Active Comparator: Pneumatic dilation
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation
Procedure: Pneumatic dilation
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope

Detailed Description:
  1. Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.
  2. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
  3. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • achalasia patients diagnosed by endoscopy, barium esophagram and manometry

Exclusion Criteria:

  • could not drink water
  • poor compliance
  • severe comorbidities
  • esophageal stenosis secondary to erosions and cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863966

Contacts
Contact: Yutang Ren, M.D. +86-020-62786224 renytpumc@hotmail.com

Locations
China
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science Recruiting
Beijing, China, 100730
Contact: Meiyun Ke, M.D.    +86-10-69155006    Kemypumch2006@yahoo.com.cn   
Principal Investigator: Yutang Ren, M.D.         
Principal Investigator: Meiyun Ke, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Director: Meiyun Ke, M.D. Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
  More Information

Publications:
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01863966     History of Changes
Other Study ID Numbers: PUMCH-AchaWater
Study First Received: May 21, 2013
Last Updated: May 23, 2013
Health Authority: China: Ethics Committee

Keywords provided by Peking Union Medical College Hospital:
Achalasia
Hot water drinking therapy
Pneumatic dilation

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 02, 2014