NCT07686471

Brief Summary

this study is prospective , randomized and interventional ,will be performed on 50 patients to compare the clinical utility , safety profile and postoperative recovery metrics between short and long per-oral endoscopic myotomy , patients will be divided randomly into two equal groups one will do short myotomy and the other group will do long myotomy , each group will contain 25 patients methodology \&patient selection : patients follow the inclusion criterias including :

  • Patients of all ages were eligible for inclusion in the study with no upper or lower age limits applied .
  • Both sexes are included .
  • Type II achalasia patients who are diagnosed by High Resolution. Manometry based on Chicago Classification (v4.0) characterized by (failed esophageal peristalsis , pan-esophageal pressurization in ≥20% of swallows and Integrated Relaxation Pressure (IRP) \>15 mmHg ).
  • Eckardt score \>3 ( moderate to severe symptoms). this study aims to compare the outcomes of short versus long esophageal myotomy in cases with type II achalasia using Eckardt score and barium study at 3 month follow up. also to evaluate difference in length of the opearation , intra-operative and post-operative adverse events between short and long submucosal tunneling. every patient will do upper endoscopy and manometry preoperative , also ekcardt score will be caculated , follow up after 3 months by barium swallow and eckardt score

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

June 24, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2028

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 24, 2026

Last Update Submit

June 29, 2026

Conditions

Esophageal Achalasia

Keywords

achalasia type II

Outcome Measures

Primary Outcomes (5)

  • change from baseline eckardt score at 3 months

    the eckardt score is a clinical grading for achalasia evaluating four symtoms dysphagia , regurgitation , retrosternal pain and weight loss ( each scored 0to3 , total score ranges from 0 to 12 where higher scores indicate severe symtoms

    3 months postoperatively

  • postoperative barium column height at 3 months

    evaluation of esophageal emptying by measuring the height of timed barium in centimeters at 1,2and 5 minutes during the barium swallow

    3 month postoperatively

  • total operative operation

    total time taken to complete the procedure , measured in minutes from initial mucosal incision to final closure

    during the operation (from incision to closure )

  • incidence of intraoperative adverse events

    number of participants who experience intraoperative complications such as mucosal perforation or significant hemorrhage during submucosal tunneling

    during the operation

  • post-operative complications

    number of participants experiencing post-operative complications ( e.g delayed bleeding , infection,or leakage )

    from the completion of operation upto the hospital discharge ( within 48 hr)

Secondary Outcomes (2)

  • length of hospital stay

    from day of the procedure until the day of official hospital discharge

  • incidence of post-operative reflux esophagitis

    3 months postoperatively

Study Arms (2)

short POEM group

EXPERIMENTAL

Per-oral endoscopic myotomy (POEM) will be performed under general anesthesia. The procedure involves four main steps: (1) mucosal incision to gain entry to the submucosal space; (2) creation of a short submucosal tunnel extending down to the esophagogastric junction; (3) short endoscopic myotomy of the circular muscle layer; and (4) closure of the mucosal entry site using endoscopic clips

Procedure: per-oral endoscopic myotomy

long POEM group

EXPERIMENTAL

Per-oral endoscopic myotomy (POEM) will be performed under general anesthesia. The procedure involves four main steps: (1) mucosal incision to gain entry to the submucosal space; (2) creation of a long submucosal tunnel extending down to the esophagogastric junction; (3) long endoscopic myotomy of the circular muscle layer; and (4) closure of the mucosal entry site using endoscopic clips.

Procedure: per-oral endoscopic myotomy

Interventions

per-oral endoscopic myotomyPROCEDURE

Per-oral endoscopic myotomy (POEM) will be performed under general anesthesia. The procedure involves four main steps: (1) mucosal incision to gain entry to the submucosal space; (2) creation of a submucosal tunnel extending down to the esophagogastric junction; (3) endoscopic myotomy of the circular muscle layer, where the longitudinal length of the myotomy (short vs. long) is determined strictly by the patient's randomized group assignment; and (4) closure of the mucosal entry site using endoscopic clips.

long POEM groupshort POEM group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Both sexes are included .
  • Type II achalasia patients who are diagnosed by High Resolution. Manometry based on Chicago Classification (v4.0) characterized by (failed esophageal peristalsis , pan-esophageal pressurization in ≥20% of swallows and Integrated Relaxation Pressure (IRP) \>15 mmHg ).
  • Eckardt score \>3 ( moderate to severe symptoms

You may not qualify if:

  • Type I ,type III achalasia \& Non-achalasia spastic motility disorders.
  • Sigmoid type esophagus (diameter\> 6 cm ).
  • Esophageal diverticulae .
  • Presence of large Hiatus Hernia ( \>5cm).
  • Severe erosive esophagitis (La Grade C or D) or Barrett's Esophagus.
  • History of previous Heller's myotomy.
  • Pseudoachalasia due to underlying malignancy.
  • Severe coagulopathy ( INR\>1.5 or platelets \<50000 ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hosoital

Asyut, 71511, Egypt

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Omar M Magdy, master dgree

    Assiut university hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

omar m magdy, Master dgree

CONTACT

+201062983336omar.megooz96@gmail.com

Magdy

CONTACT

omar.megooz96@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of internal medicine

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 7, 2026

Study Start

June 28, 2026

Primary Completion (Estimated)

June 16, 2028

Study Completion (Estimated)

December 16, 2028

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)