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Hot Water Drinking Therapy in Achalasia (AHW)

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ClinicalTrials.gov Identifier: NCT01863966
Recruitment Status : Unknown
Verified May 2013 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Achalasia Other: hot water drinking therapy Procedure: Pneumatic dilation Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
Study Start Date : March 2010
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline achalasia symptom score at 1 month [ Time Frame: baseline and 1 month ]
    Dysphagia, Regurgitation and Chest Pain scores


Secondary Outcome Measures :
  1. Number of patients with adverse effects [ Time Frame: Week 1 ]
    adverse effects of drinking water like distention, nausea and belching

  2. Change from baseline in barium esophagram at 1 year [ Time Frame: baseline and 1 year ]
    measure esophageal diameter

  3. Endoscopy at 1 year [ Time Frame: year 1 ]
    esophageal bezoars and esophageal cancer

  4. Pneumatic dilation rate and relative efficacy [ Time Frame: any time ]
    Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation

  5. Change from baseline in achalasia symptom score at 1 year [ Time Frame: baseline and 1 year ]
    Dysphagia,Regurgitation and Chest Pain scores

  6. Change from baseline achalasia symptom scores at 5 years [ Time Frame: baseline and 5 years ]
    Dysphagia,Regurgitation and Chest Pain scores

  7. Change from baseline in barium esophagram at 5 years [ Time Frame: baseline and 5 years ]
    measure esophageal diameter

  8. Endoscopy at 5 years [ Time Frame: year 5 ]
    esophageal bezoars and esophageal cancer



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01863966     History of Changes
Other Study ID Numbers: PUMCH-AchaWater
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

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