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Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy (HBOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02575014
Recruitment Status : Enrolling by invitation
First Posted : October 14, 2015
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Alexander Rosemurgy, Florida Hospital Tampa Bay Division

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.

Condition or disease Intervention/treatment Phase
Periampullary Tumor Common Bile Duct Neoplasms Duodenal Neoplasms Drug: Preoperative hyperbaric oxygen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Duodenum
Study Start Date : October 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Preoperative HBOT
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.
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.
Other Name: O2

No Intervention: No HBOT
25 out of 50 patients will not receive preoperative hyperbaric oxygen therapy. Day 1 will be the day of the operation.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Death [ Time Frame: Postoperative up to 5 years ]
  2. Length of hospital stay [ Time Frame: Postoperative up to one month ]
  3. 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,

  4. Change in Interleukin-2 [ Time Frame: Postoperative up to one month ]
  5. Change in Interleukin-6 [ Time Frame: Postoperative up to one month ]
  6. Change in Interleukin-10 [ Time Frame: Postoperative up to one month ]
  7. Change in Vascular Endothelial Growth Factor [ Time Frame: Postoperative up to one month ]
  8. Change in Transforming Growth Factor-Beta [ Time Frame: Postoperative up to one month ]
  9. Change in Erythrocyte Sedimentation Rate [ Time Frame: Postoperative up to one month ]
  10. 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

  11. Change in pain score according to visual analog scale [ Time Frame: Postoperative up to one month ]
    Postoperative pain will be compared to preoperative pain

  12. Change in Cancer Antigen 19-9 [ Time Frame: Postoperative up to one year ]
  13. Change in Carcinoembryonic antigen [ Time Frame: Postoperative up to one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients diagnosed via endoscopic ultrasound (EUS) and fine needle aspiration (FNA) or CT-guided biopsy with periampullary adenocarcinoma, duodenal cancer, premalignant lesions of the pancreas (pancreatic intraepithelial neoplasia, intraductal papillary mucinous neoplasm) and cholangiocarcinoma (Klatskin tumor) undergoing pancreaticoduodenectomy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
  • One or more comorbidities:

Diabetes Mellitus Chronic Obstructive Pulmonary Disease Cardiac Disease: history of angina, myocardial infarction, previous percutaneous cardiac intervention, or cardiac surgery, dysrhythmia Peripheral Vascular Disease: history of revascularization or amputation, rest pain, or gangrene Neurological Disease: history of stroke with or without residual deficit, seizure disorder, transient ischemic attack, hemiplegia, paraplegia, or impaired sensorium Dyspnea Bleeding Disorder Metabolic Disease (e.g. BMI ≥ 35) Renal Insufficiency Hepatic Insufficiency Another comorbidity that in the opinion of the investigator makes the patient compromised

  • Nutritionally depleted. Albumin level ≤ 3.5 grams/deciliter (g/dL)
  • Adequate organ function defined as:

Absolute neutrophil count >1,500 / (microliter) mcL Platelets >100,000 / mcL Total bilirubin <2.5 time upper limits of normal Aspartate aminotransferase (AST) / Alanine transaminase (ALT) <2.5 times institutional upper limit of normal Creatinine within normal institutional limits OR creatinine clearance >60 mL/min/ per Cockcroft-Gault equation for patients with creatinine levels above institutional normal

- Signed informed consent

Exclusion Criteria:

  • History of asthma. There is some evidence that the administration of some bronchodilators may increase the incidence of gas embolism to the brain through pulmonary vasodilation.
  • Congenital spherocytosis. Increased risk of massive hemolysis.
  • High grade fever at time of screening (more than 38.5 degree Celsius tend to lower the seizure threshold due to oxygen toxicity and may result in the delay of relatively routine therapy
  • Optic neuritis.
  • Upper respiratory tract infection and viral infection (relative contra-indications due to the difficulty such patients may have in clearing their ears and sinuses.
  • Pregnancy.
  • Emphysema with carbon dioxide retention.
  • Viral infection. There are controversial clinical evidences whether the hyperbaric oxygen therapy (HBOT) can be helpful in eliminating viral infections or otherwise viral infections may be considerably worsened after HBOT.
  • Cisplatin therapy (some evidence that this drug retards wound healing when combined with HBOT).
  • Disulphiram therapy. Evidence suggests that this drug blocks the production of superoxide dismutase. This may severely affect the body's ability to neutralize oxygen free radicals.
  • Doxorubicin therapy. This chemotherapeutic agent becomes increasingly toxic under pressure. Animal studies suggest at least a one-week break between last dose and first treatment of HBOT.
  • Claustrophobia. Some degree of confinement anxiety has been reported.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02575014

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United States, Florida
Florida Hospital Tampa
Tampa, Florida, United States, 33613
Sponsors and Collaborators
Florida Hospital Tampa Bay Division
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Principal Investigator: Alexander S Rosemurgy, MD Florida Hospital Tampa

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Responsible Party: Alexander Rosemurgy, Director, Surgical Digestive Disorders and GERD Center, Director HPB Surgery and Fellowship Program, Florida Hospital Tampa Bay Division Identifier: NCT02575014    
Other Study ID Numbers: HBOT 529762
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bile Duct Neoplasms
Duodenal Neoplasms
Common Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Common Bile Duct Diseases