| CTRI Number |
CTRI/2021/07/035105 [Registered on: 26/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Treatment of Achalasia cardia by Per oral endoscopic myotomy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Short vs Long Esophageal Myotomy for Achlasia cardia. |
|
Scientific Title of Study
|
POEM : Short vs Long Esophageal Myotomy for Achalasia cardia. A Randomised Controlled trial †|
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveer rai |
| Designation |
Professor Gastromedicine SGPGI, Lucknow |
| Affiliation |
SGPGIMS,Lucknow |
| Address |
Type IV/85, SGPGIMS Campus, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904781 |
| Fax |
|
| Email |
praveer_rai@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveer rai |
| Designation |
Professor Gastromedicine SGPGI, Lucknow |
| Affiliation |
SGPGIMS,lucknow |
| Address |
Type IV/85, SGPGIMS Campus, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904781 |
| Fax |
|
| Email |
praveer_rai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj kumar |
| Designation |
Senior resident, SGPGI, Lucknow |
| Affiliation |
SGPGIMS, Lucknow |
| Address |
MRA MULTISTORY FLAT NO 606
SGPGI CAMPUS
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904789 |
| Fax |
|
| Email |
drpankajrntmc89@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Praveer rai |
| Address |
Type IV/85, SGPGIMS Campus, Lucknow. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveer rai |
SGPGIMS, Lucknow |
Ward A & B, Gastromedicine dept.SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH |
9530157095
praveer_rai@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, SGPGIMS, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K220||Achalasia of cardia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Long esophageal myotomy |
In this group length of myotomy will be more than 6 cm |
| Intervention |
Short Esophageal Myotomy |
Length of Esophageal Myotomy will be less than 3 cm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age >18
2. Signed informed consent
3. Patient accepts to undergo scheduled follow-up after POEM 4. Eckardt score > 3
5. ASA I-II-III |
|
| ExclusionCriteria |
| Details |
1. Prior surgical treatment of achalasia
2. Pregnancy or nursing
3. Type 3 I achalasia cardia or any other esophageal motility disorder
4. Active severe esophagitis,Eosinophilic esophagitis or Barrett Esophagus
5. large lower Esophageal diverticula, Esophageal stricture
6. Large > 3cm hiatal hernia
7. Sigmoid esophagus
9. known Gastro Esophageal malignancy Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
10. Current alcohol or drug addiction.
11. Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in
12. the opinion of the investigator make the subject a poor candidate for this study.
13. Severe congenital or acquired coagulopathy or INR > 1.6 14. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Non-inferiority of a Short-POEM compared to a Long-POEM |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Basal Lower Esophageal Sphincter (LES) pressure
2. 4-second Integrated Relaxation Pressure (4sIRP)
3. Side effects and complications
4. Comparison of gastroesophageal Reflux disease (GERD) Rates
5. Operating time
6. Comparison of changes in Eckardt score
7. Change in barium column height on barium esophagogram |
1 year |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Peroral Endoscopic Myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery)[1]. The technique includes the incision of the mucosa in the esophageal body, the submucosal dissection of the distal esophagus and the creation of a submucosal tunnel in the distal esophagus and proximal gastric body, and the esophageal myotomy. The procedure is performed transorally, using a flexible endoscope[2,3]. The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure[4]. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cmin stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach [5]. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. The clinical efficacy of POEM and surgical myotomy is more likely to be similar according to the most recent published series. It is hypothesized that If shorter proximal myotomy (SM) that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one (LM), there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears [6]. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum[7,8]. In this randomized controlled trial (non-inferiority trial) we evaluate the outcomes of POEM according to the length of the esophageal myotomy. Patients undergoing POEM for type I and type II Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy. During follow-up, High Resolution Manometry (HRM), Esophageal pH-monitoring study and Esophagogastroduodenoscopy (EGD) will be regularly performed and symptoms assessed with the use of the Eckardt score (ECKs). The main hypothesis is that the results of a SM are not inferior to the results of a LM. |