Comparative Study of Per-oral Endoscopic Myotomy (POEM) in Treatment - naïve Achalasia Patients Versus Patients With Previous Pneumatic Dilation

Обзор

The aim of this study is to compare the clinical efficacy, safety, and technical outcomes of per-oral endoscopid myotomy( POEM )in treatment-naïve achalasia patients versus patients with previous pneumatic dilation. * Study subjects: 1. Inclusion criteria: Adult patients diagnosed with achalasia (Chicago classification types I-III by High resolution manometry (HRM) ). 2. Exclusion criteria: 1. Children below 18 yr. 2. Prior surgical myotomy. 3. pregnancy Groups: * Group I (Naïve group): Patients undergoing POEM as primary therapy. * Group II (Prior Pneumatic Dilation group): Patients undergoing POEM after failed or relapsed pneumatic dilation. Data analyzed included the following: * Baseline: basic demographic information, Eckardt score , manometry(HRM) , timed barium esophagogram and history of pneumatic dilation . * Perioperative parameters (Disease duration, Surgical time, Length of hospital stay, mucosal edema, and mucosal injuries). * Intraoperative (mucosal perforation ,bleeding in submucosal space ,pneumoperitoneum ,pneumomediastinum,pneumothorax or incompelet myotomy )and postoperative complications (Infections,esophageal leak ,subcutaneous emphysema, GERD,esophagitis ) . * Post procedure symptoms evaluation (Eckardt score) at 1, 3\&6 months after the procedure . Eckardt score : It is a 12-point score which is as following : 0 1 2 3 Recent weight loss (kg) none \<5 kg 5-10 kg \>10 kg Dysphagia none occasional daily each meal Retrosternal chest pain none occasional daily each meal Regurgitation none occasional daily each meal A score of ≥3 is suggestive of active achalasia. POEM technique : Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made. Technical success was defined as a successful completion of the entire POEM procedure. Clinical success was defined as a post-POEM Eckardt score of 3. * Research outcome measures: 1. Primary (main): Clinical success at 3 and 6 months (Eckardt score ≤ 3 ) 2. Secondary (subsidiary): * Technical success * Procedure time * Intra- and post-operative complications. Data management and analysis : Data will be collected first in sheets, and then will be in Master sheet. Data of every patient will be coded. This will be done using SPSS. Categorical data were presented as number and percentage. Continuous data is presented as mean and standard deviation (SD) if normally distributed or median and interquartile range (IQR) if non normal distributed. Other test will be used according to the results and relations needed to be studied.

Вмешательства

• Процедура per-oral endoscopic myotomy (POEM)
  Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior

Первичные конечные точки

• Clinical success at 3 and 6 months (Eckardt score ≤ 3 ) [Срок оценки: 6 months]

Вторичные конечные точки (3)

• - Technical success [Срок оценки: 1 day ( the day of the procedure )]
• procedure time [Срок оценки: 1 day ( the day of the procedure)]
• Intraoperative & post operative complications [Срок оценки: up to 6 months after the procedure]

Критерии участия

Критерии включения

• Adult patients diagnosed with achalasia (Chicago classification types I-III by High resolution manometry (HRM) ).

Критерии исключения

• Children below 18 yr.
• Prior surgical myotomy.
• pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07287787 · 04-2025-100435

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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