POEM Anterior Versus Posterior Approach
Primary Purpose
Achalasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peroral Endoscopic Myotomy
Sponsored by
About this trial
This is an interventional treatment trial for Achalasia
Eligibility Criteria
Inclusion Criteria for Participants
- Adult patient age greater than 18 years old
- Confirmed diagnosis of achalasia via high resolution esophageal manometry (HREM)
Exclusion Criteria
- Previous surgery of the esophagus or stomach
- Active severe esophagitis
- Large lower esophageal diverticula
- Large > 3cm hiatal hernia
- Sigmoid esophagus
- Known gastroesophageal malignancy
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Acute gastrointestinal bleeding
- Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anterior Approach
Posterior Approach
Arm Description
For the anterior approach, an incision will be made in the 1 to 2 o'clock position of the esophageal wall.
For the posterior approach, a mucosal incision will be made at the 5 to 6 o'clock position
Outcomes
Primary Outcome Measures
Change in Eckardt Score
The standardized clinical scoring system for achalasia will be assessed at 2 weeks, 3 months, 6 months, and 1 year post procedure. The score is based on the results of a self- administered questionnaire using 4 items related to digestive symptoms including weight loss, dysphagia, retrosternal pain, and regurgitation. Each item is rated from 0 to 3 (0= none, 1= occasional, 2=daily, 3=with every meal).
Secondary Outcome Measures
Rate of GERD by pH-impedance
This is assessed by the DeMeester score. The score is comprised of the following: Percent total time pH < 4, Percent Upright time pH < 4, Percent Supine time pH < 4, Number of reflux episodes, Number of reflux episodes ≥ 5 min, Longest reflux episode (minutes). The abnormal reflux is defined as DeMeester score >14.72
Quality of Life by QoL S36 questionnaire
The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
Dysphagia by the Dysphagia Score
Dysphagia scoring system scores dysphagia as follows:
0 = able to eat normal diet / no dysphagia; 1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia.
Postoperative pain by VAS analogue scale
The visual analogue scales scores the severity of the pain from zero (minimum) to 10 (maximum).
Analgesic use by Analgesic Quantification Algorithm
Analgesic Quantification Algorithm scoring scores analgesic use from zero (minimum) to 7 (maximum) as follows:
0= No analgesic; 1= Non-opioid analgesics; 2= Weak opioids (For example, codeine and tramadol); 3= Strong opioids ≤75 mg OME per day; 4= Strong opioids >75-150 mg OME per day; 5= Strong opioids >150-300 mg OME per day; 6= Strong opioids >300-600 mg OME per day ; 7=Strong opioids >600 mg OME per day
Operative and post-operative complications
Hospital stay in days
LES pressure by Manometry
Total procedure time and times of different steps
Technical success
Defined as completion of the procedure using the assigned approach
Ease of procedure measured by the Lickerdt scale
The ease of the procedure scored by the endoscopist on a Likert scale rated from 1 (easy) to 5 (impossible).
Full Information
NCT ID
NCT02454335
First Posted
May 10, 2015
Last Updated
December 28, 2017
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02454335
Brief Title
POEM Anterior Versus Posterior Approach
Official Title
Comparison of Outcome and Complications of Anterior Versus Posterior Myotomy in Per-oral Endoscopic Myotomy (POEM) Endoscopic Procedure for Treatment of Achalasia: Randomized Single Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.
Detailed Description
Peroral Endoscopic Myotomy (POEM) is an effective, minimally-invasive treatment for achalasia that has been adopted over the past few years. As more programs attempt to adopt the novel technique, there is an increased need for trials to help guide the growth of the procedure. Review of the current literature reveals that most endoscopists prefer an anterior approach, with an incision in the anterior/ anterolateral wall of the esophagus. This approach has been used with tremendous success in decreasing the symptoms of dysphagia and lowering esophageal sphincter (LES) pressure since the first description of the procedure in humans in 2010. However, it can be technically challenging in patients with anterior scarring from prior surgery or radiation, in whom a posterior approach has typically been used. Alternatively, the posterior approach, with incision in the posterolateral wall of the esophagus, has been adopted with great success by several endoscopists as the primary approach to myotomy. Reports involving the posterior approach have also shown significant symptom relief as defined by symptoms score (Eckardt score) < 3, decreased LES pressure, and low complication rates.
However, despite high rates of technical and clinical success, the posterior approach has not been as widely adopted as the anterior approach. Without comparison of the two approaches in terms of efficacy and safety, the optimal technique to myotomy for POEM is yet to be defined. The investigators main hypothesis is that the posterior myotomy is as efficacious as the anterior myotomy in terms of improvement of achalasia symptoms as indicated by reduction in the Eckardt score and LES pressure. Adaptation of both techniques may increase options in approach for routine POEM and increase the number of patients that are able to undergo the procedure, thereby promoting its applicability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior Approach
Arm Type
Active Comparator
Arm Description
For the anterior approach, an incision will be made in the 1 to 2 o'clock position of the esophageal wall.
Arm Title
Posterior Approach
Arm Type
Active Comparator
Arm Description
For the posterior approach, a mucosal incision will be made at the 5 to 6 o'clock position
Intervention Type
Procedure
Intervention Name(s)
Peroral Endoscopic Myotomy
Other Intervention Name(s)
POEM
Intervention Description
The intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry.
Primary Outcome Measure Information:
Title
Change in Eckardt Score
Description
The standardized clinical scoring system for achalasia will be assessed at 2 weeks, 3 months, 6 months, and 1 year post procedure. The score is based on the results of a self- administered questionnaire using 4 items related to digestive symptoms including weight loss, dysphagia, retrosternal pain, and regurgitation. Each item is rated from 0 to 3 (0= none, 1= occasional, 2=daily, 3=with every meal).
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Rate of GERD by pH-impedance
Description
This is assessed by the DeMeester score. The score is comprised of the following: Percent total time pH < 4, Percent Upright time pH < 4, Percent Supine time pH < 4, Number of reflux episodes, Number of reflux episodes ≥ 5 min, Longest reflux episode (minutes). The abnormal reflux is defined as DeMeester score >14.72
Time Frame
up to 24 months
Title
Quality of Life by QoL S36 questionnaire
Description
The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
Time Frame
up to 2 years
Title
Dysphagia by the Dysphagia Score
Description
Dysphagia scoring system scores dysphagia as follows:
0 = able to eat normal diet / no dysphagia; 1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia.
Time Frame
up to 24 months
Title
Postoperative pain by VAS analogue scale
Description
The visual analogue scales scores the severity of the pain from zero (minimum) to 10 (maximum).
Time Frame
2 years
Title
Analgesic use by Analgesic Quantification Algorithm
Description
Analgesic Quantification Algorithm scoring scores analgesic use from zero (minimum) to 7 (maximum) as follows:
0= No analgesic; 1= Non-opioid analgesics; 2= Weak opioids (For example, codeine and tramadol); 3= Strong opioids ≤75 mg OME per day; 4= Strong opioids >75-150 mg OME per day; 5= Strong opioids >150-300 mg OME per day; 6= Strong opioids >300-600 mg OME per day ; 7=Strong opioids >600 mg OME per day
Time Frame
up to 24 months
Title
Operative and post-operative complications
Time Frame
up to 2 years
Title
Hospital stay in days
Time Frame
up to 24 months
Title
LES pressure by Manometry
Time Frame
up to 2 years
Title
Total procedure time and times of different steps
Time Frame
up to 24 months
Title
Technical success
Description
Defined as completion of the procedure using the assigned approach
Time Frame
up to 24 months
Title
Ease of procedure measured by the Lickerdt scale
Description
The ease of the procedure scored by the endoscopist on a Likert scale rated from 1 (easy) to 5 (impossible).
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Participants
Adult patient age greater than 18 years old
Confirmed diagnosis of achalasia via high resolution esophageal manometry (HREM)
Exclusion Criteria
Previous surgery of the esophagus or stomach
Active severe esophagitis
Large lower esophageal diverticula
Large > 3cm hiatal hernia
Sigmoid esophagus
Known gastroesophageal malignancy
Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
Cirrhosis with portal hypertension, varices, and/or ascites
Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
Acute gastrointestinal bleeding
Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31408652
Citation
Khashab MA, Sanaei O, Rivory J, Eleftheriadis N, Chiu PWY, Shiwaku H, Ogihara K, Ismail A, Abusamaan MS, El Zein MH, Wong VW, Billioux VG, Kumbhari V, Kalloo AN, Ponchon T, Pioche M. Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial. Gastrointest Endosc. 2020 Feb;91(2):288-297.e7. doi: 10.1016/j.gie.2019.07.034. Epub 2019 Aug 10.
Results Reference
derived
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POEM Anterior Versus Posterior Approach
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