Clinical Trial: Hot Water Drinking Therapy in Achalasia

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients

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 Summary:

  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

Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Change from baseline achalasia symptom score at 1 month [ Time Frame: baseline and 1 month ]

Dysphagia, Regurgitation and Chest Pain scores


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with adverse effects [ Time Frame: Week 1 ]
    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 ]
    measure esophageal diameter
  • Endoscopy at 1 year [ Time Frame: year 1 ]
    esophageal bezoars and esophageal cancer
  • Pneumatic dilation rate and relative efficacy [ Time Frame: any time ]
    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 ]
    Dysphagia,Regurgitation and Chest Pain scores
  • Change from baseline achalasia symptom scores at 5 years [ Time Frame: baseline and 5 years ]
    Dysphagia,Regurgitation and Chest Pain scores
  • Change from baseline in barium esophagram at 5 years [ Time Frame: baseline and 5 years ]
    measure esophageal diameter
  • Endoscopy at 5 years [ Time Frame: year 5 ]
    esophageal bezoars and esophageal cancer


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: May 21, 2013
Date Started: March 2010
Date Completion: December 2015
Last Updated: May 23, 2013
Last Verified: May 2013