Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine
About this trial
Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.
Refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ
Endoluminal planimetry: EGJ-DI < 3 mm2/mmHg (with 40ml)
Disqualifiers
No previous attempt with at least one prokinetic drug
Previous esophageal myotomy (open, laparoscopic or endoscopic)
Primary esophageal motility disorder (achalasia etc.)
Active erosive esophagitis
Trial design
Design model
Single group
Treatments tested in this trial
Per Oral Endoscopic Myotomy (POEM)
Procedure/SurgeryAll procedures will be performed by an experienced endoscopist, with a sufficient experience in "third space" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the procedure consists of 4 steps: (1) mucosal incision and tunnel entry, (2) submucosal tunneling, (3) myotomy, and (4) closure of the mucosal entry with endoscopic clips or other closure devices. Perioperative protocol might differ according the usual way of performing POEM in a given center.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: POEM armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy and safety of POEM in patients with postfundoplication dysfagia
The primary outcome will be proportion of patients with treatment success defined as Eckardt score ≤ 2 and its decrease by at least 1 point after POEM at 6 months
Time frame
6 monthsSecondary outcomes
1
Eckardt score
The Eckardt score is the grading system used for the evaluation of severity of symptoms in patients with esophageal achalasia. Four symptoms are assessed (dysphagia, regurgitation, chest pain and weight loss) and their severity ranges from 0 (no symptom) to 3 (with every meal). Total score is their sum and ranges from 0 to 12
Time frame
At baseline and after 3, 6 and 12 months2
Mellow - Pinkas score
The Mellow - Pinkas score is used to assess dysphagia grade before and after the interventions. Total score ranges from 0 to 3 (0 = able to eat normal diet, 1 = able to swallow some solid foods, 2 = able to swallow only semi solid foods, 3 = able to swallow liquids only)
Time frame
At baseline and after 3, 6 and 12 months3
PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)
The PAGI-QoL questionnaire contains of 30 items with five subscales: (1) daily activities; (2) clothing; (3) diet/food habits; (4) relationship; and (5) psychological well-being and distress. Each item is scored on a 6-point Likert scale, with response options ranging from 0 (none) to 5 (severe problem all of the time). Subscale scores are calculated by averaging the item responses. A total score is calculated by averaging subscale scores. Higher score means impairment in quality of life.
Time frame
At baseline and after 3, 6 and 12 months4
GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)
The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Higher (greater) possible score means worst symptoms - ranging from 0 to 75.
Time frame
At baseline and after 3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute for Clinical and Experimental Medicine
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Sponsor institution
University Hospital Trnava
Collaborator
St. Anne's University Hospital Brno, Czech Republic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: