A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

NCT00188344 | Unknown DMC

• 2 other identifiers: MCT-76449ISRCTN05714772
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy in patients with achalasia in order to learn which of these two treatments should be recommended to patients in the future.

Conditions

Esophageal Achalasia

Keywords

laparoscopic myotomy; pneumatic dilatation; motility disorder; dysphasia; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• The achalasia severity questionnaire score at 1 year.

  Baseline, M2, M6, Yrs 1 to 5

Secondary Outcomes (5)

• Generic health related quality of life (SF-36)

  baseline, M2, M6, Yrs 1 to 5

• Gastrointestinal disease-specific quality of life (GIQLI)

  baseline, M2, M6, Yrs 1 to 5

• Measures of esophageal physiology

  baseline, M6

• Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement

  M6

• Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes.

  Yrs 1 to 5

Study Arms (2)

1

ACTIVE COMPARATOR

pneumatic dilatation

Procedure: pneumatic dilatation

2

ACTIVE COMPARATOR

Laparoscopic myotomy

Procedure: laparoscopic myotomy with partial fundoplication

Interventions

pneumatic dilatation PROCEDURE

The patient is on a liquid diet for 2 days prior to procedure. A sedative and pain killer by IV are given and the throat will be sprayed with local anesthetic. The gastroenterologist may perform an endoscopy prior to the dilatation to safely guide the dilator into position. A special dilator with a small balloon will be passed down the esophagus until it meets the stomach then the balloon will be inflated with air until the narrow part of the esophagus is opened. The patient will then be assessed for any perforation of the esophagus and monitored in the post-procedure unit for a few hours.

1

laparoscopic myotomy with partial fundoplication PROCEDURE

The abdomen is inflated with gas and cameras and instruments are inserted. The junction between the esophagus and stomach is identified. The muscle of the lower esophageal sphincter is divided. A portion of the stomach wall is secured to the lower esophagus. After surgery the patient is taken to the recovery room and when well enough moved to a ward. The patient may be discharged the following day.

2

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of achalasia by a physician
• manometric diagnosis of achalasia including both: Incomplete relaxation of the lower esophageal sphincter during swallowing (\<80% of elevation over intragastric pressure and absence of esophageal peristalsis (peristalsis in \<20% of initiated contractions)
• Facility with English, ability to complete English language questionnaires

You may not qualify if:

• Pseudoachalasia: esophageal carcinoma; esophageal stricture; previous esophageal or gastric surgery; previous instrumentation of the lower esophageal sphincter i.e. suture, polymer injection, silicone band
• Previous gastric or esophageal surgery: fundoplication; Heller myotomy; gastric resection; vagotomy with or without gastric drainage
• Age 17 year or less
• Pregnancy
• Presence of severe comorbid illness: unstable angina; recent myocardial infarction (\<6 months), cancer (except integumentary), unless free of disease for more than 5 years; end stage renal disease; previous stroke with cognitive, motor speech, or swallowing deficit persisting longer than one month; severe respiratory disease; cognitive impairment

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Esophageal Achalasia; Aphasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David R Urbach, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2015
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

CA (2)