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Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)

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ClinicalTrials.gov Identifier: NCT02138643
Recruitment Status : Unknown
Verified April 2017 by University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2014
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:

Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax the lower esophageal sphincter ( LES) in response to swallowing associated with lack of peristalsis of the esophageal body. Its most common clinical presentation is dysphagia , and occasionally chest pain , regurgitation , aspiration pneumonia and weight loss , resulting in a large impact on daily activities and quality of life of affected individuals .

There is currently considered curative treatment for achalasia , dysphagia relief being the primary therapeutic target and is forced to relax the LES by endoscopy or surgery. Thus , the most commonly used endoscopic treatments are forced dilatation of the cardia and botulinum toxin. Laparoscopic Heller myotomy with antireflux procedure with therapy is considered "gold standard " because of excellent results and minimal invasiveness. Currently , pneumatic dilation and surgical treatment with the Heller myotomy with fundoplication are strongly associated with the best therapeutic options available .

In recent years, the possibility of using endoluminal access in the treatment of achalasia patients through the technique originally described as Natural orifices Translumenal Endoscopic Surgery ( NOTES) and continuing advances in the submucosal dissection has enabled the concomitant development of a new approach described as perioral endoscopic myotomy . In 2007, Pasricha et al , described the feasibility of endoscopic esophageal myotomy through a submucosal tunnel initially in an animal model . The first performance of this procedure in humans was described by Inoue et al , in 2010 , introducing the concept of transluminal endoscopic surgery through natural orifices , with the objective of minimizing the trauma and all the stress resulting from open surgical procedure . These authors call the procedure as POEM ( Per Oral Endoscopic myotomy ) .


Condition or disease Intervention/treatment Phase
Dysphagia Achalasia Procedure: Endoscopic surgery Procedure: Laparoscopic surgery Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)
Actual Study Start Date : February 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Endoscopic surgery
Patients with symptomatic achalasia confirmed by clinical and laboratory tests, which meet the criteria for inclusion and exclusion. These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)
Procedure: Endoscopic surgery
These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)

Sham Comparator: Laparoscopic surgery
Patients with symptomatic achalasia confirmed by clinical and laboratory tests, which meet the criteria for inclusion and exclusion. These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.
Procedure: Laparoscopic surgery
These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.




Primary Outcome Measures :
  1. Remission of symptoms dysphagia. [ Time Frame: 12 months after the procedure performed. ]
    Patient selection will last for six months after the beginning of the study. Six months later, conduct additional examinations and randomization. Twelve months after the start of the project will be the completion of endoscopic surgery or laparoscopic surgery for resolution of dysphagia. The measure is a composite.


Secondary Outcome Measures :
  1. Running time of the procedure and hospitalization. [ Time Frame: Starts 12 months after procedure performed. ]
    New outpatient medical visits for clinical reassessment, more precisely 30 days, 3 months, 6 months and 12 months after the procedure will be scheduled to measure the execution time of the procedure and hospitalization. The measure is a composite.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 18 and 70 years diagnosed with symptomatic achalasia (dysphagia score ≥ II and Eckardt> 3) all grades including Rezende classification and Chicago Classification.
  • Patients who agree to participate in the study and signed an informed consent.

Exclusion Criteria:

  • Treatment (s) prior (s) achalasia.
  • Patients with a history of esophageal, mediastinal and / or gastric surgery (except for gastric perforation).
  • Patients with liver cirrhosis and / or esophageal varices, Barrett's esophagus, esophageal stricture, premalignant or malignant esophageal lesions and coagulopathy.
  • Patients with severe cardiopulmonary disease or other serious illness that results in a high surgical risk.
  • Patients diagnosed with pseudoachalasia
  • Patients diagnosed with diverticulum in the distal esophagus.
  • Pregnancy and lactation.

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): NCT02138643


Locations
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Brazil
Hospital das Clínicas da FMUSP
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Paulo Sakai Hospital das Clínicas da FMUSP
Study Director: Eduardo Turiani H de Moura Hospital das Clínicas FMUSP

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02138643     History of Changes
Other Study ID Numbers: 23460613000000068
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Sao Paulo General Hospital:
Achalasia
Megaesophagus
Peropal endoscopic myotomy(POEM)
Laparoscopic Heller myotomy
Additional relevant MeSH terms:
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Esophageal Achalasia
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Motility Disorders