Local Triamcinolone Injection Combined With Fibrin Glue Spray in Preventing Esophageal Stricture After Big-range Endoscopic Submucosal Dissection for Esophageal Early Cancer

NCT06840561 | Completed Phase 2 DMC

• 2 other identifiers: G2021-075-01A2022440
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic submucosal dissection (ESD) is the main treatment for esophageal early cancer. But post-ESD stricture has a serious impact on quality of life.When the lesion range reaches up to 3/4 circumferential mucosal defect or the longitudinal length over 5cm, the esophageal stricture rate will be over 70% or more, and when the whole circumferential mucosal defect, the rate is up to 100%. Local triamcinolone (TA) injection has positive effect on post-ESD stricture.But there are no uniform standards and results of the TA usage. Investigators also found a disadvantage that TA injection was hard to be absorbed completely in the submucosal layer and spilled over easily, which may decrease the preventive effect. The investigators tried to make a better protocol that could adjust the time and frequency of triamcinolone injection to improve the medicine duration of stay and decrease the stricture rate. So, the aim of this study was to investigate the efficacy and safety of TA injection in a new way for preventing post-ESD stricture. This is a single-center prospective intervention study, and single-arm trial too, which is carried out at Sun Yat-Sen University Cancer Center in Guangzhou, China. Participants recruited into the study must meet the standards as follows: (a). be staged as cT1aN0M0 or cT1bN0M0 before surgery via magnifying endoscopy, endosonography, CT, or PET/CT; (b). refuse conventional surgery and CRT and get ESD as first-line treatment; (c). mucosal defect measured by a circular protractor and reached more than three-quarters of the circumference of the esophageal lumen including whole circumference after ESD surgery; (d). sign the consent before ESD;(e). meet the minimum follow-up period of three months. In the protocol, TA injection combined with fibrin glue was used twice, immediately (D0) and 7days(D7) after ESD to increase TA's residual time and effect in the study group. Meanwhile, the stickiness of fibrin glue can protect the wound for preventing perforation or bleeding. The dosage of TA and fibrin glue were 100mg and 5-10ml in every session separately. The first target of this study was the frequency of stricture lasting at least three months follow-ups. And the second targets were the number of endoscopic bougie dilation or balloon dilation (EBD), stricture classification, stooler score and complications in the study group. The expectational results are as follows: the first is that TA injection combined with firin glue spray can greatly decrease the esophgeal stricture rate after long-range ESD; the second is that TA injection combined with firin glue spray can also decrease the frequency of endoscopic bougie dilation or balloon dilation (EBD), complications, and the degree of stricture classification and stooler score compared with historical data. This study will show that TA injection combined with fibrin glue spray is a safe and effective treatment in preventing post-ESD stricture of esophageal early cancer.

Conditions

Esophageal Stricture; Endoscopic Submucosal Dissection; Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

Keywords

Local triamcinolone injection; fibrin glue spray; endoscopic submucosal dissection; esophageal stricture

Outcome Measures

Primary Outcomes (1)

• The frequency of post-ESD stricture

  After three months follow-ups, the stricture rate will be calculated in the study group with Local triamcinolone injection combined with fibrin glue spray. Esophageal stricture is defined as couldn't get through by Q260 gastroscope (Olympus, Japan, diameter 9.2mm).

  From ESD surgery to the end of follow-up at least three months

Secondary Outcomes (1)

• The number of endoscopic bougie dilation or balloon dilation (EBD) and degree of stricture classification, and stooler score in the study group

  The time frame of degree of stricture classification and stooler score is three months follow-up. The time frame of EBD is from the date of stricture confirmed untile the date of study ended.

Other Outcomes (1)

• The complications of local TA injection combined with fibrin glue spray

  Three months follow-up

Study Arms (1)

the study group

EXPERIMENTAL

Drug: Local triamcinolone injection combined with fibrin glue spray

Interventions

Local triamcinolone injection combined with fibrin glue spray DRUG

TA injection and fibrin glue spray are used in two sessions after ESD immediately (D0) and 7 days later(D7). In the first session, triamcinolone (40mg/1ml/ampul, China) in 100mg total quantity is diluted with 10ml saline to make a 4mg/0.5ml solution and injected in the surface of post-wound symmetrically at 25 points (0.5ml/point) depending on the defective area. But TA injection should avoid muscular injury place. We check the wound to make sure there is no bleeding or perforation after the TA injection, then spray 5-10ml fibrin glue (Porcine fibrin sealant kit, China) on the injection wound. The spray dosage is depending on the wound area. The key point is that the glue could cover all the injection wound. Seven days later, the protocol is carried out again.

the study group

Eligibility Criteria

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

You may qualify if:

• staged as cT1aN0M0 or cT1bN0M0 before surgery via magnifying endoscopy, endosonography, CT, or PET/CT;
• refuse conventional surgery and CRT and got ESD as first-line treatment;
• mucosal defect measured by a circular protractor and reached more than three-quarters of the circumference of the esophageal lumen including whole circumference after ESD surgery;
• meet the minimum follow-up period of three months;
• signed the consent before ESD;
• If extra treatment is needed after ESD, it is up to current guidelines.

You may not qualify if:

• excessive bleeding and perforation happened during the ESD procedure;
• excessive bleeding and perforation happened during TA injection;
• loss to follow-up or not meet three months follow-up periods;
• allergy to triamcinolone or fibrin glue;
• esophageal recurrence in situ during follow-up period

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Esophageal Stenosis; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Qing Yang, MM

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor of the department of endoscopy

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 21, 2025
• Study Start: November 24, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1years and ending 3 years after the publication of results

Locations

CN (1)