TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

NCT ID: NCT02135627

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-07-31

Brief Summary

Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery. All exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13). The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14). More robust controlled evaluative data are now needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (RCT).

Conditions

MALIGNANT GASTROINTESTINAL BLEEDING

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Current standard endoscopic therapy such as epinephrine injection, sclerotherapy, mechanical (endoclip). contact electrocautery/thermal, and non-contact electrocalcautery (APC) ± radiation therapy, angioembolization, and/or surgery.

Group Type: EXPERIMENTAL

Current standard therapy

Intervention Type: OTHER

TC-325

TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.

Group Type: ACTIVE_COMPARATOR

TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.

Intervention Type: DRUG

Interventions

TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.

Intervention Type: DRUG

Current standard therapy

Intervention Type: OTHER

Other Intervention Names

epinephrine injection,; sclerotherapy,; mechanical (endoclip).; contact electrocautery/thermal; non-contact electrocalcautery (APC) ± radiation therapy,; angioembolization,; surgery

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
• Patients who present with an upper or lower GI bleeding with a known luminal GI malignancy diagnosed within the past two years will be considered for enrolment. Endoscopic confirmation of an active GI bleed arising from a malignant tumor will be required for final inclusion
• Rebleeding in patients who presented with acute GIB with initial endoscopy suggesting a malignant source based on endoscopic appearance who have not been treated previously with TC-325 will also be included

Exclusion Criteria

• Refused by patient
• Pregnancy
• Bleeding from non-malignant GI sources such as gastritis/duodenitis, Mallory Weiss syndrome, peptic ulcer disease, varices, vascular malformations, radiation proctitis, polyps, hemorrhoids, and diverticulosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASGE

UNKNOWN

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Alan Barkun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University Health Center

Montreal, Quebec, Canada

Countries

Canada

References

Chen YI, Wyse J, Lu Y, Martel M, Barkun AN. TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial. Gastrointest Endosc. 2020 Feb;91(2):321-328.e1. doi: 10.1016/j.gie.2019.08.005. Epub 2019 Aug 19.

Reference Type: DERIVED

PMID: 31437456 (View on PubMed)

Other Identifiers

13-251-BMD

Identifier Type: -

Identifier Source: org_study_id