To Evaluate Efficacy of Red Dichromatic Imaging (RDI) in Achieving Hemostasis During POEM Using GF 1500 UGI Scope

NCT05476458 | Unknown FDA Device

• 1 other identifier: RDIH-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

POEMS Syndrome; Hemostatic Disorder

Keywords

Red Dichromatic Imaging; Achieving hemostasis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Use of RDI in comparison with white light imaging in achieving haemostasis (haemostasis time) after 1 month and 6 months

Study Arms (2)

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.

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

Radiation: White Light Imaging

Interventions

White Light Imaging RADIATION

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.

White light imaging

Red Light Imaging RADIATION

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.

Red Dichromatic Imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Upto 80 - 100 subjects

You may qualify if:

• Consecutive consenting patients of both gender posted for POEM in the department of Medical Gastroenterology, AIG Hospitals.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (2)

Aig Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

POEMS Syndrome; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunoproliferative Disorders; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders

Study Officials

• Mohan Ramchandani, MBBS

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Pradev Inavolu, MBBS

CONTACT

9963088053; pradev32@gmail.com

Neeraj Singla, MBBS

CONTACT

7888619216; dr.neerajsingla@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 27, 2022
• Study Start: August 15, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)