Short Versus Long Submucosal Tunneling in Per-oral Endoscopic Myotomy (POEM) for Type II Achalasia.

Short Versus Long Submucosal Tunneling in Per-oral Endoscopic Myotomy (POEM) for Type II Achalasia: A Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Achalasia
• Intervention / Treatment: Procedure: per-oral endoscopic myotomy

Detailed Description

Aim of the study :

Primary outcome :

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.

to evaluate difference in length of the opearation , intra-operative and post-operative adverse events between short and long submucosal tunneling.

Secondary outcome :

We aim to compare the difference in duration of hospital stay between short and long esophageal myotomy .

We aim to compare the incidence of post-operative Gastroesophageal Reflux Disease (GERD) using Los Angeles (LA) classification via upper endoscopy at 3 months.

Patients and Methods Study Design: prospective , randomized . Patients:this study will include all patients diagnosed as type II achalasia via High Resolution Manometry , this study will be conducted in internal medicine department at Assiut University Hospitals between june 2026 to june 2028.

Inclusion criteria:

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).

Exclusion criteria :

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 ).

Methodology :

All patients will be subjected to the following:

Preoperative evaluation:

•Eckardt score: All patients were assessed using the Eckardt score for symptom severity, which is based on dysphagia, chest pain, regurgitation, and weight loss symptoms. Each component of the Eckardt score is assigned a value from 0 to 3 according to the patient's self-reported response, with the total score ranging from 0 to 12. Higher scores indicate more severe symptoms.(7)

Upper Gastrointestinal Endoscopy :

Patients shoud be fasting for 8 hours and the procedure was performed under general anesthesia It is used to comment on esophageal peristalsis, dilatation, LES, any residual food were noted.

High Resolution Manometry :

All the patients assessed by High Resolution Manometry , for evaluation of esophageal peristalsis, LES pressure, integral resting pressure (IRP), and ineffective contractions and to differentiate between achalasia types.

Certain instructions were followed :

Patients were instructed to stop any medication that may influence esophageal motility (calcium channel blocker, nitrates, loperamide, prokinetics, beta-blocker, and opioids).

Patients were instructed for complete fasting for 12h before procedure. An HRM catheter was introduced transnasally in the supine position and positioned by observing the appearance of a high-pressure zone at the distal end of the LES.

Patients were instructed not to swallow for 30 s to detect the resting pressure among esophagus.

Patients were then instructed to take 5ml of water in each swallow of 10 successive swallows separated by 30 s interval for assessment of esophageal body peristalsis.(8)

Barium swallow :

it is performed to all patients to detect bird peak appearance , dilated esophagus ,retained food or sigmoid esophagus.

Hematological investigation :

Venous blood samples will be drawn into 2 mL EDTA tubes. Complete blood count will be analyzed within 2 hours after venipuncture using an automated hematology analyzer. The parameters analyzed will be Hemoglobin, platelet count and White Blood Cells.

Differential leucocyte counts will be done on peripheral smear. Neutrophil -to-Lymphocyte Ratio (NLR) will be calculated.

Other hematological parameters will be done like (CRP and ESR ). Coagulation profile (PC , PT ,INR )

Per-oral Endoscopic Myotomy Technique :

POEM was performed by experienced endoscopist . All procedures were performed under general anesthesia with the patients in the supine position. POEM was performed by anterior (1-2 O'clock) route in all cases. The steps of POEM procedure were as follows:

submucosal injection using a solution of saline mixed with indigocarmine dye . vertical mucosal incision measuring 2 cm to 2.5 cm in length. submucosal tunneling extending up to 2 cm to 4 cm below the Gastroesophageal junction ( GEJ) .

myotomy extending from 1 cm to 2 cm below the distal edge of mucosal incision until the lower end of the tunnel and closure of the mucosal incision with several endoclips ,Triangular tip knife (KD-645L; Olympus, Tokyo, Japan) with integrated water jet function was utilized for the entire procedure including mucosal incision, submucosal tunneling, and myotomy (Spray Coag 50 W).

The important technical differences in the short and long myotomy groups were as follows. The length of esophageal myotomies (≤ 3 cm vs ≥ 6 cm) were different in both groups. Whereas, the length of gastric myotomies were similar (2-4 cm) in either group. In the short myotomy group, the mucosal incision was performed at about 5-6 cm above the gastroesophageal junction (GEJ). The length of esophageal myotomy was 2 cm to 3 cm and the entire extent of the myotomy was full thickness in the short myotomy group. Whereas in the long myotomy group, the mucosal incision was performed at least 8 cm above the GEJ and the length of esophageal myotomy was ≥ 6 cm. Selective circular myotomy was performed in the upper part of the tunnel and full thickness myotomy was performed from 2-3 cm above the GEJ until the lower end of the tunnel. The length of gastric myotomy was kept similar in both groups ie, 2-4 cm. The extent of esophageal and gastric myotomies were assessed using scope withdrawal, and fluoroscopy . In cases with uncertainty regarding the gastric length of myotomy, double scope method was used for confirmation.(9) Adverse events: events requiring an additional procedure such as needle drainage for capno-peritoneum, temporary cessation of procedure due to accumulation of retroperitoneal CO2 , mucosal injuries requiring closure with endoclips, and intra-procedural or post-procedural events leading to prolongation of hospital stay were considered as adverse events.(10)

Postoperative evaluation :

All patients will be followed up by hematological investigations like CBC , CRP and ESR to all patients 24 hrs postoperative.

All patients will be followed up by barium swallow and Eckardt score at 3 month duration .

All patients will be underwent upper endoscopy at 3 months duration .

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: omar m magdy, Master dgree; Phone Number: +201062983336; Email: omar.megooz96@gmail.com
• Study Contact Backup: Name: Magdy; Email: omar.megooz96@gmail.com

Study Locations

• Egypt
  • Asyut, Egypt, 71511
    • Assiut university hosoital
    • Contact: omar M magdy, Master degree; Phone Number: 01062983336; Email: omar.megooz96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: short POEM group; 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; 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.
Experimental: long POEM group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	total number of days spent in the hospital , calculatef from day of the procedure until the day of official hospital discharge	from day of the procedure until the day of official hospital discharge
incidence of post-operative reflux esophagitis	the percentage of participants diagnosed with gastresophageal reflux disease ( GERD)evaluated via upper gastrointestinal endoscopy and graded according to los angelos(LA) classification system (grades A to D , where higher grades indicate more severe mucosal breaks	3 months postoperatively

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Omar M Magdy, master dgree, Assiut university hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): June 16, 2028
• Study Completion (Estimated): December 16, 2028

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: achalasia type II
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Achalasia
• Other Study ID Numbers: 04-2026-100498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No