Preoperative Hyperbaric Oxygen Therapy (HBOT) vs. Non Preoperative HBOT in Patients Undergoing Pancreaticoduodenectomy for Premalignant, and Malignant Tumors of the Common Bile Duct, Periampullary and Duodenum
Description:
Patients diagnosed with premalignant and malignant tumors of the common bile duct,
periampullary and duodenum will be screened for eligibility within 4 weeks of their scheduled
surgery. Initiation of therapy is defined as the first day of HBOT for patients receiving
HBOT therapy (Arm A) and the day of surgery for patients not receiving HBOT (Arm B). Patients
will be considered "enrolled into study" once the consent form has been signed, all screening
procedures have been undertaken and all the eligibility criteria are met. The fifty eligible
patients will be randomized in a 1:1 ratio the same day of the screening process. The
eligible subjects undergoing HBOT will be treated with up to 2.4 Atmospheres Absolute (ATA)
of oxygen (O2), for a maximum of 90 minutes each day with or without air breaks, as deemed
necessary by the investigator, for two days. Patients who are deemed ineligible will receive
the same standard of care without any exceptions. The start day of the week to commence HBOT
will be Monday through Wednesday, as the second and final day of HBOT treatment will be the
day in which the patient undergoes pancreaticoduodenectomy. The subjects who complete the
HBOT regimen must undergo subsequent pancreaticoduodenectomy within five hours of termination
of HBOT. If there is more than a five hour delay from completion of the HBOT to commencement
of operation, the subject will be considered "off study treatment". However, "off study
treatment" patients will continue to be followed up every six months for the first thirty
months, and annually thereafter. During the postoperative period, clinical data and
questionnaire forms will be collected on day 1, day 3, day 5, and one month (± 2 weeks)
during the first year. As for secondary objectives, the investigators will collect clinical
data from patients during their follow up visits in the office, by contacting them on the
phone, or by mailing them the protocol specific questionnaires every 6 months for 5 years.
Condition:
Periampullary Tumor
Treatment:
Preoperative hyperbaric oxygen
Start Date:
October 2013
Sponsor:
Florida Hospital Tampa Bay Division
For More Information:
https://clinicaltrials.gov/show/NCT02575014