NCT05688020

Brief Summary

Endoscopic resection of gastrointestinal lesions may prevent cancer. However, resection is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of upper gastrointestinal lesions.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

January 5, 2023

Last Update Submit

August 6, 2023

Conditions

Gastric PolypGastric NeoplasmDuodenal NeoplasmsEsophageal Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Intraprocedural bleeding

    To compare the severity of intraprocedural bleeding between those receiving TXA and those receiving epinephrine.

    During procedure

  • Postprocedural bleeding

    To compare the severity of postprocedural bleeding between those receiving TXA and those receiving epinephrine.

    2 weeks post-procedure

Secondary Outcomes (1)

  • Side effects

    2 weeks post-procedure

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

During the ER procedure, de-identified injectate solution will be introduced. Study group: 9 ml of standart solution for injection \[Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)\] + 1 ml (100mg) of TXA (tranexamic acid).

Drug: Tranexamic acid

Epinephrine

ACTIVE COMPARATOR

During the ER procedure, de-identified injectate solution will be introduced. 9 ml of standart solution for injection \[Consisit of: 6 ml indigo carmine + 500 ml succinylated gelatin 4% (Gelofusine; B. Braun, Crissier, Switzerland)\] + 1 ml epinephrine 1:100,000 + 1 ml saline 0.9%.

Drug: Epinephrine injection

Interventions

Tranexamic acidDRUG

Tranexamic acid will be injected as part of the injectate during endoscopic resection.

Also known as: Hexakapron
Tranexamic acid
Epinephrine injectionDRUG

Epinephrine will be injected as part of the standard injectate used during endoscopic resection.

Also known as: Adrenaline
Epinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for endoscopic resection of a non-neoplastic and neoplastic lesions in the upper GI presenting to our tertiary academic center.
  • Age \> 18 years

You may not qualify if:

  • patients with histories of allergic reactions to TXA
  • history of seizures
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, 70300, Israel

RECRUITING

Related Publications (7)

  • ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.

    PMID: 26077453BACKGROUND

  • Park CH, Lee SK. Preventing and controlling bleeding in gastric endoscopic submucosal dissection. Clin Endosc. 2013 Sep;46(5):456-62. doi: 10.5946/ce.2013.46.5.456. Epub 2013 Sep 30.

    PMID: 24143302BACKGROUND

  • Libanio D, Pimentel-Nunes P, Dinis-Ribeiro M. Complications of endoscopic resection techniques for upper GI tract lesions. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):735-748. doi: 10.1016/j.bpg.2016.09.010. Epub 2016 Sep 14.

    PMID: 27931633BACKGROUND

  • Yang Z, Wu Q, Liu Z, Wu K, Fan D. Proton pump inhibitors versus histamine-2-receptor antagonists for the management of iatrogenic gastric ulcer after endoscopic mucosal resection or endoscopic submucosal dissection: a meta-analysis of randomized trials. Digestion. 2011;84(4):315-20. doi: 10.1159/000331138. Epub 2011 Nov 9.

    PMID: 22075541BACKGROUND

  • Castro R, Libanio D, Pita I, Dinis-Ribeiro M. Solutions for submucosal injection: What to choose and how to do it. World J Gastroenterol. 2019 Feb 21;25(7):777-788. doi: 10.3748/wjg.v25.i7.777.

    PMID: 30809079BACKGROUND

  • Watts G. Utako Okamoto. Lancet. 2016 Jun 4;387(10035):2286. doi: 10.1016/s0140-6736(16)30697-3. No abstract available.

    PMID: 27308678BACKGROUND

  • Montroy J, Hutton B, Moodley P, Fergusson NA, Cheng W, Tinmouth A, Lavallee LT, Fergusson DA, Breau RH. The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis. Transfus Med Rev. 2018 Feb 19:S0887-7963(17)30151-7. doi: 10.1016/j.tmrv.2018.02.003. Online ahead of print.

    PMID: 29567052BACKGROUND

MeSH Terms

Conditions

Polyposis, GastricStomach NeoplasmsDuodenal NeoplasmsEsophageal Neoplasms

Interventions

Tranexamic AcidEpinephrine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsDuodenal DiseasesIntestinal DiseasesHead and Neck NeoplasmsEsophageal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Anton Bermont, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anton Bermont, MD

CONTACT

972-52-6944145bermont@doctor.com

Sergei Vosko, MD

CONTACT

sergeivosko@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is designed as a prospective, double-blinded, controlled, non-inferiority pilot study.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 18, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2026

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)