RCT of Gastric ESD With or Without Epineprhine Added Solution

NCT04032119 | Completed Phase 3 DMC

• 1 other identifier: EPI-ESD RCT01
• Study Type: interventional
• Target: 800
• Locations: 4 countries
• Sites: 7

Brief Summary

This is an international multi-center randomised controlled study comparing outcomes of gastric endoscopic submucosal dissection (ESD) with or without addition of epinephrine in the submucosal injection solution.

Conditions

Gastric Neoplasm; Early Gastric Cancer

Keywords

Gastric Endoscopic submucosal dissection; Epinephrine

Outcome Measures

Primary Outcomes (1)

• Overall procedural time

  From the beginning of mucosal incision till the end of submucosal dissection, excluding time for prophylactic homeostasis

  During the endoscopic procedure

Secondary Outcomes (15)

• Number of intra-procedural hemorrhage events

  During the endoscopic procedure

• Maximum systolic blood pressure

  During the endoscopic procedure

• Maximum heart rate

  During the endoscopic procedure

• Adverse event - Delayed hemorrhage

  30 days

• Adverse event - Perforation

  30 days

Study Arms (2)

Epinephrine

EXPERIMENTAL

0.2ml 1:10000 epinephrine diluted into each 20ml of the original solution for submucosal injection

Procedure: Endoscopic submucosal dissection; Drug: Epinephrine

Non-epinephrine

ACTIVE COMPARATOR

No epinephrine would be added into the solution

Procedure: Endoscopic submucosal dissection

Interventions

Endoscopic submucosal dissection PROCEDURE

Endoscopic submucosal dissection

Epinephrine; Non-epinephrine

Epinephrine DRUG

Epinephrine

Epinephrine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Selection criteria: Presence of intramucosal neoplastic lesions in the stomach planning for endoscopic submucosal dissection (Vienna Classification Category 3 and 4 lesion)
• Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation

You may not qualify if:

• Recurrent / remnant lesion after previous endoscopic resection
• Lesions arising from surgical anastomotic site, such as gastrojejunostomy / gastroduodenostomy.
• Marked electrolyte abnormalities
• Hemostatic or coagulative abnormalities
• Patient on anti-coagulant agents, including warfarin and other direct oral anti-coagulants (those on antiplatelet can be included)
• Failure of vital organ (heart, lungs, liver, or kidneys) function
• Allergic to components of injection solutions: Epinephrine, hyaluronic acid etc
• Other cases deemed by the examining physician as unsuitable for safe treatment

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Osaka International Cancer Institute: collaborator
• Fukuoka University: collaborator
• Changi General Hospital: collaborator
• Kyoto 2nd Red Cross Hospital: collaborator
• Ishikawa Prefectural Central Hospital: collaborator
• Kosin University Gospel Hospital: collaborator
• Machida General Hospital: collaborator
• Nara City Hospital: collaborator
• Wakayama Red Cross Hospital: collaborator
• JCHO Osaka Hospital: collaborator
• Sapporo Kinentou hospital: collaborator
• Japan Community Healthcare Organization Osaka Hospital: collaborator

Study Sites (7)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Ishikawa Prefecture Central Hospital

Ishikawa, Japan

Location

Kyoto 2nd Red Cross Hospital

Kyoto, Japan

Location

Osaka International Cancer Institute

Osaka, Japan

Location

Shizuoka Cancer Center

Shizuoka, Japan

Location

Changi General Hospital

Singapore, Singapore

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Related Publications (1)

• Yip HC, Uedo N, Iwagami H, Waki K, Ohtsu K, Miyaoka M, Yao K, Akamatsu T, Konishi T, Nakano S, Nakanishi H, Doyama H, Machida H, Jung K, Chiu P, Iwasaki T, Uchita K, Kawamura T, Takizawa K, Kitamura Y, Li JW, Ang TL, Shimokawa T, Zhu Z, Yung MY. The use of diluted epinephrine during gastric endoscopic submucosal dissection: an international randomized controlled trial. Gastrointest Endosc. 2026 Jan 29:S0016-5107(26)00072-6. doi: 10.1016/j.gie.2026.01.031. Online ahead of print.

  PMID: 41620139 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection; Epinephrine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hon Chi Yip, MBChB, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: January 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4); SG (1); HK (1); KR (1)