Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05476458 |
Other study ID # |
RDIH-01 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 15, 2022 |
Est. completion date |
July 1, 2023 |
Study information
Verified date |
May 2023 |
Source |
Asian Institute of Gastroenterology, India |
Contact |
Dr Pradev Inavolu, MBBS |
Phone |
9963088053 |
Email |
pradev32[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Peroral endoscopic myotomy (POEM) is a novel endoscopic technique for the treatment of
achalasia and other esophageal motility disorders. Initially, it was introduced to the world
by Inoue et al. in 2008.7 Thereafter; it was rapidly disseminated because of low
invasiveness, higher efficacy and technical novelty. The steps of performing POEM include
mucosal incision, submucosal tunnel creation, myotomy and closure of the incision. Mucosotomy
(2.8%) is the most common adverse event in patients undergoing POEM.8 It can be due to
excessive use of cautery because bleeding points could not be seen clearly with white light
during active ooze. RDI will help in early recognition of the bleeding points, thus prompt
hemostasis. Bleeding during POEM is not very uncommon(0.5-0.7%).9 Early recognition of
bleeding points and quicker hemosasis help in decreasing complications. The utility of RDI in
the peroral endoscopic myotomy is not studied so far to our knowledge. Hence in this study we
would like to look into the utility of red dichromatic imaging in per-oral endoscopic
myotomy.
Description:
After obtaining departmental and ethics committee clearance, study will be conducted in AIG
Hospitals, Hyderabad. Written informed consent will be taken from the patient or relative
before enrolling into the study. After enrolment, participants were allocated into Red
dichromatic imaging group(Group 1) and White light imaging group(Group 2). All patients will
undergo endoscopy prior to the procedure.
All the procedures in this study will be performed by single endoscopic trainee, previously
performed less than ten procedures.
Red Dichromatic Imaging (RDI) works by employing green, amber and red wavelength.
- Green light (520-550nm)
- Amber (595-610nm)
- Red Light (620-640nm)
Group 1: Per-oral endoscopic myotomy will be performed using novel Evis X1 endoscopy(Olympus
corporation, Tokyo, Japan) system. RDI mode 1 and Mode 2 will be used during the procedure.
Submucosal bleb will be created by injecting mixture of indigo carmine and normal saline. RDI
mode 2 will be used for submucosal injection and Mucosal incision. RDI Mode 2 helps in
detection of deep mucosal or submucosal vessels which are the major cause of bleeding.
Submucosal dissection and myotomy will be performed under white light. However when there is
bleeding, RDI mode 1 will be used for the detection of bleeding point. Bleeding will be
controlled with spray coagulation or using Coagrasper. Hemostasis treatment will be performed
by switching to RDI only at the time of bleeding during the procedure.
Group 2: Per-oral endoscopic myotomy will be performed using CV-190 Gastroscope (Olympus
corporation, Tokyo, Japan). White light imaging is used during entire procedure. Submucosal
bleb will be created by injecting mixture of indigo carmine and normal saline. Initial
submucosal injection and Mucosal incision will be performed under white light. RDI Entry
point bleed and ease of entry into the tunnel will be marked by trainee at the end of the
procedure. Submucosal dissection and myotomy will be performed under white light. When there
is bleeding, bleeding point is identified with white light and hemostasis is achieved.