NCT02575014

Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Florida Hospital Tampa Bay Division · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety, tolerability and toxicity of preoperative HBOT in patients undergoing a pancreaticoduodenal resection for premalignant and malignant tumors of the common bile duct, periampullary and duodenum.

Detailed 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.

Conditions

• Periampullary Tumor
• Common Bile Duct Neoplasms
• Duodenal Neoplasms

Interventions

Type	Name	Description
DRUG	Preoperative hyperbaric oxygen	Subjects undergoing preoperative HBOT 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, for two days. The two days will be the day of and the day immediately prior to the operation.

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-12-01
• Completion: 2022-12-01
• First posted: 2015-10-14
• Last updated: 2018-02-07

Locations

1 site across 1 country: United States