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

NCT05476458 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-05-31

No results posted yet for this study

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

Interventions

RADIATION

White Light Imaging

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.

RADIATION

Red Light Imaging

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Mohan Ramchandani, MBBS · Principal Investigator

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Device
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05476458 on ClinicalTrials.gov