Clinical trial NCT02138643: Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)
Official title: Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Achalasia
Keywords: Achalasia
Megaesophagus
Peropal endoscopic myotomy(POEM)
Laparoscopic Heller myotomy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ) .

Detailed description: 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 .

Epidemiological data show an incidence in the United States and Europe , approximately 1/200.000 and no predilection for sex, age group (mean between 25 and 60 years) was observed , as well as any other demographic group . In Brazil , the incidence is approximate 7-13/100.000 inhabitants .

Large proportion of patients with symptomatic achalasia require additional tests for diagnosis. Endoscopy ( EDA ) despite being regarded as a major test for initial evaluation of dysphagia , presents serious limitations to evaluate esophageal motility , especially in early stages . Some contrast studies , highlighting the Esophagogram barium ( DSE ) , provide additional anatomical findings as esophageal shape and size , as well as functional : peristalsis , the LES function and bolus clearance through the esophagogastric junction ( TEG ) . Another useful method of diagnosis is the Esophageal manometry , with characteristic (Chicago Classification of Distal Esophageal Motility Disorders ) : aperistalsis the esophageal body and failure to relax the LES , currently best characterized by High Resolution Manometry .

Idiopathic achalasia is confined to the esophagus and has no established etiology , with agenesis of the myenteric plexus or viral infections , in particular herpes simplex ( HSV - 1 ) , the most likely hypothesis . In Brazil , the secondary achalasia caused by Chagas disease predominantly among other etiologies , involves but is expressed primarily systemic disease with esophageal involvement . Infected patients Typanossoma cruzi, the causative agent of Chagas disease , 7-10 % have esophageal involvement, and due to its chronic nature the most common clinical presentation is megaesophagus , to varying degrees .

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 .

Many studies have validated the efficacy of pneumatic dilation in some cases exceeding 90%, but with the limitation of the need for serial dilations , the main complication being perforation , around 8 % .

With the introduction of minimally invasive surgery , surgical approach has gained great clinical importance , especially for laparoscopic Heller myotomy with antireflux valve ( fundoplication ) . With a success rate ranging between 89 and 100 % in recent studies , provide a more lasting relief of symptoms without the need for additional interventions , compared to pneumatic dilation .

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 ) .

OBJECTIVE The primary objective of this protocol is to compare the efficacy between surgical approach through laparoscopic myotomy with fundoplication associated Heller myotomy and endoscopic peroral ( POEM ) in the treatment of patients with achalasia regardless of its etiology .

Eligibility 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.

Primary outcomes:
measure: Remission of symptoms dysphagia.
timeFrame: 12 months after the procedure performed.
Secondary outcomes:
measure: Running time of the procedure and hospitalization.
timeFrame: Starts 12 months after procedure performed.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP
state: SP
Study officials:
affiliation: Hospital das Clínicas da FMUSP
name: Paulo Sakai
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clínicas FMUSP
name: Eduardo Turiani H de Moura
role: STUDY_DIRECTOR
References: