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Preoperative hyperbaric oxygen for Duodenal Neoplasms (HBOT Trial)

N/A
Waitlist Available
Led By Alexander S Rosemurgy, MD
Research Sponsored by Florida Hospital Tampa Bay Division
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative up to one year
Awards & highlights

HBOT Trial Summary

This trial will test if it is safe to give patients hyperbaric oxygen therapy before surgery to remove tumors in the bile duct, ampulla of Vater, or duodenum.

Eligible Conditions
  • Duodenal Neoplasms
  • Periampullary Tumors
  • Bile Duct Tumors

HBOT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with hyperbaric oxygen treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Secondary outcome measures
Change in Cancer Antigen 19-9
Change in Carcinoembryonic antigen
Change in Erythrocyte Sedimentation Rate
+10 more

HBOT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Preoperative HBOTExperimental Treatment1 Intervention
25 out of 50 patients will receive 2 preoperative hyperbaric oxygen therapy treatments, one the day before their operation, the other within 5 hours preceding their operation. The participants will be treated with up to 2.4 ATA O2, for a maximum of 90 minutes each day with or without air breaks, as deemed necessary by the investigator. Day 0 will be the first day of their HBOT treatment, Day 1 will be the day of their operation and second/final HBOT treatment.
Group II: No HBOTActive Control1 Intervention
25 out of 50 patients will not receive preoperative hyperbaric oxygen therapy. Day 1 will be the day of the operation.

Find a Location

Who is running the clinical trial?

Florida Hospital Tampa Bay DivisionLead Sponsor
6 Previous Clinical Trials
540 Total Patients Enrolled
Alexander S Rosemurgy, MDPrincipal InvestigatorFlorida Hospital Tampa
2 Previous Clinical Trials
866 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy
Alexander Rosemurgy 2013. "Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02575014.
~4 spots leftby Apr 2025
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