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

Last updated: May 29, 2023
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Thrombocytopenic

Treatment

White Light Imaging

Red Light Imaging

Clinical Study ID

NCT05476458
RDIH-01
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • • 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 toprocedure
  • Breast feeding, pregnant and lactating women's

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: White Light Imaging
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
July 01, 2023

Study 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.

Connect with a study center

  • Aig Hospitals

    Hyderabad, Telangana 500032
    India

    Active - Recruiting

  • Asian Institute of Gastroenterology

    Hyderabad, Telangana 500082
    India

    Active - Recruiting

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