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

NCT02138643 | Unknown DMC

• 1 other identifier: 23460613000000068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 ) .

Conditions

Dysphagia; Achalasia

Keywords

Achalasia; Megaesophagus; Peropal endoscopic myotomy(POEM); Laparoscopic Heller myotomy

Outcome Measures

Primary Outcomes (1)

• Remission of symptoms dysphagia.

  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.

  12 months after the procedure performed.

Secondary Outcomes (1)

• Running time of the procedure and hospitalization.

  Starts 12 months after procedure performed.

Study Arms (2)

Endoscopic surgery

ACTIVE COMPARATOR

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

Laparoscopic surgery

SHAM COMPARATOR

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

Interventions

Endoscopic surgery PROCEDURE

These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)

Endoscopic surgery

Laparoscopic surgery PROCEDURE

These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.

Laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Deglutition Disorders; Esophageal Achalasia

Interventions

Endoscopy; Laparoscopy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Paulo Sakai

  Hospital das Clínicas da FMUSP

  PRINCIPAL INVESTIGATOR

• Eduardo Turiani H de Moura

  Hospital das Clínicas FMUSP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: May 14, 2014
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)