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