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Hot Water Drinking Therapy in Achalasia (AHW)

Primary Purpose

Achalasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hot water drinking therapy
Pneumatic dilation
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring Achalasia, Hot water drinking therapy, Pneumatic dilation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hot water drinking therapy

Pneumatic dilation

Arm Description

Hot water drinking before,after meal and before sleep

Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation

Outcomes

Primary Outcome Measures

Change from baseline achalasia symptom score at 1 month
Dysphagia, Regurgitation and Chest Pain scores

Secondary Outcome Measures

Number of patients with adverse effects
adverse effects of drinking water like distention, nausea and belching
Change from baseline in barium esophagram at 1 year
measure esophageal diameter
Endoscopy at 1 year
esophageal bezoars and esophageal cancer
Pneumatic dilation rate and relative efficacy
Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation
Change from baseline in achalasia symptom score at 1 year
Dysphagia,Regurgitation and Chest Pain scores
Change from baseline achalasia symptom scores at 5 years
Dysphagia,Regurgitation and Chest Pain scores
Change from baseline in barium esophagram at 5 years
measure esophageal diameter
Endoscopy at 5 years
esophageal bezoars and esophageal cancer

Full Information

First Posted
May 21, 2013
Last Updated
May 23, 2013
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01863966
Brief Title
Hot Water Drinking Therapy in Achalasia
Acronym
AHW
Official Title
Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
Achalasia, Hot water drinking therapy, Pneumatic dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hot water drinking therapy
Arm Type
Experimental
Arm Description
Hot water drinking before,after meal and before sleep
Arm Title
Pneumatic dilation
Arm Type
Active Comparator
Arm Description
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation
Intervention Type
Other
Intervention Name(s)
hot water drinking therapy
Intervention Description
Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep
Intervention Type
Procedure
Intervention Name(s)
Pneumatic dilation
Intervention Description
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope
Primary Outcome Measure Information:
Title
Change from baseline achalasia symptom score at 1 month
Description
Dysphagia, Regurgitation and Chest Pain scores
Time Frame
baseline and 1 month
Secondary Outcome Measure Information:
Title
Number of patients with adverse effects
Description
adverse effects of drinking water like distention, nausea and belching
Time Frame
Week 1
Title
Change from baseline in barium esophagram at 1 year
Description
measure esophageal diameter
Time Frame
baseline and 1 year
Title
Endoscopy at 1 year
Description
esophageal bezoars and esophageal cancer
Time Frame
year 1
Title
Pneumatic dilation rate and relative efficacy
Description
Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation
Time Frame
any time
Title
Change from baseline in achalasia symptom score at 1 year
Description
Dysphagia,Regurgitation and Chest Pain scores
Time Frame
baseline and 1 year
Title
Change from baseline achalasia symptom scores at 5 years
Description
Dysphagia,Regurgitation and Chest Pain scores
Time Frame
baseline and 5 years
Title
Change from baseline in barium esophagram at 5 years
Description
measure esophageal diameter
Time Frame
baseline and 5 years
Title
Endoscopy at 5 years
Description
esophageal bezoars and esophageal cancer
Time Frame
year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yutang Ren, M.D.
Phone
+86-020-62786224
Email
renytpumc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meiyun Ke, M.D.
Organizational Affiliation
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiyun Ke, M.D.
Phone
+86-10-69155006
Email
Kemypumch2006@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yutang Ren, M.D.
First Name & Middle Initial & Last Name & Degree
Meiyun Ke, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
9649001
Citation
Triadafilopoulos G, Tsang HP, Segall GM. Hot water swallows improve symptoms and accelerate esophageal clearance in esophageal motility disorders. J Clin Gastroenterol. 1998 Jun;26(4):239-44. doi: 10.1097/00004836-199806000-00003.
Results Reference
result
PubMed Identifier
23105999
Citation
Ren Y, Ke M, Fang X, Zhu L, Sun X, Wang Z, Wang R, Wei Z, Wen P, Xin H, Chang M. Response of esophagus to high and low temperatures in patients with achalasia. J Neurogastroenterol Motil. 2012 Oct;18(4):391-8. doi: 10.5056/jnm.2012.18.4.391. Epub 2012 Oct 9.
Results Reference
result

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Hot Water Drinking Therapy in Achalasia

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