POEMS SyndromeRDIH-01NCT05476458
To Evaluate Efficacy of Red Dichromatic Imaging (RDI) in Achieving Hemostasis During POEM Using GF 1500 UGI Scope
An observational study of POEMS Syndrome and Hemostatic Disorder, run by Asian Institute of Gastroenterology, India at 2 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- POEMS Syndrome, Hemostatic Disorder
- What is being tested?
- White Light Imaging and Red Light Imaging
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesIndia
- Study dates
- 15 Aug 2022to 1 Jul 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Upto 80 - 100 subjects
Who may be able to join
- • Consecutive consenting patients of both gender posted for POEM in the department of Medical Gastroenterology, AIG Hospitals.
Who cannot join
- • Patients aged under 18 years of age
- Unable to provide informed consent
- Inherited or acquired coagulopathy likely to affect the risk of bleeding
- Receiving anticoagulant therapy that could not be stopped or bridged prior to procedure
- Breast feeding, pregnant and lactating women's
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Aig Hospitals
Hyderabad, Telangana, 500032
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
About this study
Official title: Prospective, Randomized, Single Center Study to Evaluate Efficacy of Red Dichromatic Imaging (RDI) in Achieving Hemostasis During Peroral Endoscopic Myotomy Using GF 1500 UGI Scope: A Pilot Study
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.
Read the detailed 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.
- Conditions
- POEMS Syndrome, Hemostatic Disorder
- Being tested
- White Light Imaging, Red Light Imaging
- Keywords
- Red Dichromatic Imaging, Achieving hemostasis
- Medical subject headings
- POEMS Syndrome, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Light ImagingRadiation
white light imaging is often the preferred option for poem surgery due to its effective results. However, it also comes with some drawbacks that make it difficult to identify areas of bleeding, unlike RDI, WLI cannot enhance the visibility of deep vessels This can lead to longer haemostasis time as the physician must wait for a longer period before stopping the bleeding. This can make it challenging as it may lead to excessive bleeding. This makes RDI a potential solution for those seeking a more accurate approach to treatment.
Red Light ImagingRadiation
Red dichromatic imaging (RDI) is a next-generation image enhancement technique which works by employing green, amber and red wavelengths. Greenlight(520-550nm) can visualize small blood vessels in superficial tissue without extending deep into the mucosa. Amber(595-610nm) and red light (620-640nm) can penetrate deep into the tissue owing to low scattering property. The blood vessels in the deeper tissues absorb the amber light because of strong affinity with hemoglobin. Even though red light can penetrate deep into the tissue, it is weakly absorbed by hemoglobin. Hence the reflected light contains red light and amber light without attenuation.
| Study group | Role | What they receive |
|---|---|---|
| Red Dichromatic Imaging | 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. Receives: Radiation: Red Light Imaging | |
| White light imaging | 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 Receives: Radiation: White Light Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM
To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM
Measured: To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM
Secondary outcomes (1)
To identify avascular mucosal site by identifying and avoiding deep blood vessels using RDI after 1 month and 6 month
Psychological stress experienced by endoscopists during haemostasis treatment as assessed on a scale of 1-5 (1) no stress. (2) minor stress (3) moderate stress (4) high stress (5) very high stress, Ease of mucosal entry by using RDI when compared to white light imaging.
Measured: Use of RDI in comparison with white light imaging in achieving haemostasis (haemostasis time) after 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start15 Aug 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POEMS SyndromeStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Ramchandani, MBBS, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476458
- Sponsor's protocol ID
- RDIH-01
- Acronym
- RDIH-01
- Status last verified
- May 2023
- First submitted
- 25 May 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single Center Study to Evaluate Efficacy of Red Dichromatic Imaging (RDI) in Achieving Hemostasis During Peroral Endoscopic Myotomy Using GF 1500 UGI Scope: A Pilot Study
- ClinicalTrials.gov ID
- NCT05476458
- Acronym / sponsor ID
- RDIH-01 / RDIH-01
- Conditions
- POEMS Syndrome, Hemostatic Disorder
- Keywords
- Red Dichromatic Imaging, Achieving hemostasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Dichromatic Imaging | – | Radiation: Red Light ImagingPer-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. |
| White light imaging | – | Radiation: White Light ImagingPer-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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Upto 80 - 100 subjects
Key inclusion criteria (1 listed)
- • Consecutive consenting patients of both gender posted for POEM in the department of Medical Gastroenterology, AIG Hospitals.
Key exclusion criteria (5 listed)
- • Patients aged under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White Light Imagingwhite light imaging is often the preferred option for poem surgery due to its effective results. However, it also comes with some drawbacks that make it difficult to identify areas of bleeding, unlike RDI, WLI cannot enhance the visibility of deep vessels This can lead to longer haemostasis time as the physician must wait for a longer period before stopping the bleeding. This can make it challenging as it may lead to excessive bleeding. This makes RDI a potential solution for those seeking a more accurate approach to treatment. | Radiation | White light imaging |
| Red Light ImagingRed dichromatic imaging (RDI) is a next-generation image enhancement technique which works by employing green, amber and red wavelengths. Greenlight(520-550nm) can visualize small blood vessels in superficial tissue without extending deep into the mucosa. Amber(595-610nm) and red light (620-640nm) can penetrate deep into the tissue owing to low scattering property. The blood vessels in the deeper tissues absorb the amber light because of strong affinity with hemoglobin. Even though red light can penetrate deep into the tissue, it is weakly absorbed by hemoglobin. Hence the reflected light contains red light and amber light without attenuation. | Radiation | Red Dichromatic Imaging |
Primary outcome
To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM
Time frame: To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM
To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM
1 secondary outcome
To identify avascular mucosal site by identifying and avoiding deep blood vessels using RDI after 1 month and 6 month
Time frame: Use of RDI in comparison with white light imaging in achieving haemostasis (haemostasis time) after 1 month and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
Related trials for POEMS Syndrome
RecruitingPhase 2
BCMA/CD3 BsAb Therapy for POEMS Syndrome
POEMS Syndrome
RecruitingObservational study
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
Multiple Myeloma, Amyloidosis
Active, not recruitingObservational study
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy
RecruitingPhase 2
KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
POEMS Syndrome
RecruitingObservational study
One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS
AL Amyloidosis, POEMS Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Ramchandani, MBBS principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of POEMS Syndrome and Hemostatic Disorder, run by Asian Institute of Gastroenterology, India at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Pradev Inavolu, MBBS (9963088053, pradev32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM (time frame: To determine the change in total procedural time using Red dichromatic imaging (RDI) compared to white light imaging in achieving haemostasis during POEM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.