Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia

Sponsor
Institute for Clinical and Experimental Medicine
Study ID
NCT06872255
Status
Not Yet Recruiting

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Conditions

  • Dysphagia
  • Dysphagia, Esophageal
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Per Oral Endoscopic Myotomy (POEM) — PROCEDURE
    All 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.

Study Details

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.

Key Dates

First listed
Mar 12, 2025
Start date
Apr 1, 2025
Status verified
Feb 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: POEM arm
    Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia

Primary Outcome Measure

Efficacy and safety of POEM in patients with postfundoplication dysfagia [ Time Frame: 6 months ]

Central Contacts

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