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DysphagiaNCT02138643

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

A study testing Endoscopic surgery and Laparoscopic surgery in people with Dysphagia and Achalasia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dysphagia, Achalasia
What is being tested?
Endoscopic surgery and Laparoscopic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBrazil
Study dates
Feb 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital das Clínicas da FMUSP

    São Paulo, São Paulo, 05403000

Other trials in Brazil

About this study

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 ) .

Read the 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 .

Conditions
Dysphagia, Achalasia
Being tested
Endoscopic surgery, Laparoscopic surgery
Keywords
Achalasia, Megaesophagus, Peropal endoscopic myotomy(POEM), Laparoscopic Heller myotomy
Medical subject headings
Deglutition Disorders, Esophageal Achalasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic surgeryProcedure or surgery

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

  • Laparoscopic surgeryProcedure or surgery

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

Study groups in NCT02138643
Study groupRoleWhat they receive
Endoscopic surgeryActive comparatorPatients 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)
Receives: Procedure: Endoscopic surgery
Laparoscopic surgerySham comparatorPatients 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.
Receives: Procedure: Laparoscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months after the procedure performed.

Secondary outcomes (1)
  1. Running time of the procedure and hospitalization.

    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.

    Measured: Starts 12 months after procedure performed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2014 (estimated)
  2. Study startFeb 2016
  3. Primary completionNov 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138643
Sponsor's protocol ID
23460613000000068
Status last verified
Apr 2017
First submitted
16 Apr 2014
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic surgery and Laparoscopic surgery in people with Dysphagia and Achalasia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission of symptoms dysphagia. (time frame: 12 months after the procedure performed.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.

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