Clinical Trial: Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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 questionnaire
Sponsor: Florida Hospital Tampa Bay Division

Current Primary Outcome: Number of participants with hyperbaric oxygen treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Preoperative ]

ear pain, oxygen toxicity, visual changes, embolism, pneumothorax, fatigue


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Death [ Time Frame: Postoperative up to 5 years ]
  • Length of hospital stay [ Time Frame: Postoperative up to one month ]
  • Postoperative complications [ Time Frame: Postoperative up to one month ]
    Surgical wound infections, hernia, abscess, fluid collection, bleeding, anastomotic leak, thromboembolic events, pulmonary atelectasis, bronchospasm, pneumonia, stroke, myocardial ischemia, myocardial infarction, time to extubation for patients requiring prolonged mechanical assistance, biliary or pancreatic fistula, fever, blood transfusion, delayed gastric emptying,
  • Change in Interleukin-2 [ Time Frame: Postoperative up to one month ]
  • Change in Interleukin-6 [ Time Frame: Postoperative up to one month ]
  • Change in Interleukin-10 [ Time Frame: Postoperative up to one month ]
  • Change in Vascular Endothelial Growth Factor [ Time Frame: Postoperative up to one month ]
  • Change in Transforming Growth Factor-Beta [ Time Frame: Postoperative up to one month ]
  • Change in Erythrocyte Sedimentation Rate [ Time Frame: Postoperative up to one month ]
  • Change in Quality of Life QOL-C30 v1.0 [ Time Frame: Postoperative up to 5 years ]
    Postoperative quality of life scores will be compared to preoperative quality of life
  • Change in pain score according to visual analog scale [ Time Frame: Postoperative up to one month ]
    Postoperative pain will be compared to preoperative pain
  • Change in Cancer Antigen 19-9 [ Time Frame: Postoperative up to one year ]
  • Change in Carcinoembryonic antigen [ Time Frame: Postoperative up to one year ]


Original Secondary Outcome: Same as current

Information By: Florida Hospital Tampa Bay Division

Dates:
Date Received: October 7, 2015
Date Started: October 2013
Date Completion: December 2022
Last Updated: June 27, 2016
Last Verified: June 2016