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Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy (HBOT)

Primary Purpose

Periampullary Tumor, Common Bile Duct Neoplasms, Duodenal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative hyperbaric oxygen
Sponsored by
Florida Hospital Tampa Bay Division
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periampullary Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Hospital Tampa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preoperative HBOT

No HBOT

Arm Description

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.

25 out of 50 patients will not receive preoperative hyperbaric oxygen therapy. Day 1 will be the day of the operation.

Outcomes

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

Secondary Outcome Measures

Death
Length of hospital stay
Postoperative complications
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
Change in Interleukin-6
Change in Interleukin-10
Change in Vascular Endothelial Growth Factor
Change in Transforming Growth Factor-Beta
Change in Erythrocyte Sedimentation Rate
Change in Quality of Life QOL-C30 v1.0
Postoperative quality of life scores will be compared to preoperative quality of life
Change in pain score according to visual analog scale
Postoperative pain will be compared to preoperative pain
Change in Cancer Antigen 19-9
Change in Carcinoembryonic antigen

Full Information

First Posted
October 7, 2015
Last Updated
February 6, 2018
Sponsor
Florida Hospital Tampa Bay Division
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1. Study Identification

Unique Protocol Identification Number
NCT02575014
Brief Title
Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy
Acronym
HBOT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Hospital Tampa Bay Division

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Tumor, Common Bile Duct Neoplasms, Duodenal Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative HBOT
Arm Type
Experimental
Arm Description
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.
Arm Title
No HBOT
Arm Type
No Intervention
Arm Description
25 out of 50 patients will not receive preoperative hyperbaric oxygen therapy. Day 1 will be the day of the operation.
Intervention Type
Drug
Intervention Name(s)
Preoperative hyperbaric oxygen
Other Intervention Name(s)
O2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with hyperbaric oxygen treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Description
ear pain, oxygen toxicity, visual changes, embolism, pneumothorax, fatigue
Time Frame
Preoperative
Secondary Outcome Measure Information:
Title
Death
Time Frame
Postoperative up to 5 years
Title
Length of hospital stay
Time Frame
Postoperative up to one month
Title
Postoperative complications
Description
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,
Time Frame
Postoperative up to one month
Title
Change in Interleukin-2
Time Frame
Postoperative up to one month
Title
Change in Interleukin-6
Time Frame
Postoperative up to one month
Title
Change in Interleukin-10
Time Frame
Postoperative up to one month
Title
Change in Vascular Endothelial Growth Factor
Time Frame
Postoperative up to one month
Title
Change in Transforming Growth Factor-Beta
Time Frame
Postoperative up to one month
Title
Change in Erythrocyte Sedimentation Rate
Time Frame
Postoperative up to one month
Title
Change in Quality of Life QOL-C30 v1.0
Description
Postoperative quality of life scores will be compared to preoperative quality of life
Time Frame
Postoperative up to 5 years
Title
Change in pain score according to visual analog scale
Description
Postoperative pain will be compared to preoperative pain
Time Frame
Postoperative up to one month
Title
Change in Cancer Antigen 19-9
Time Frame
Postoperative up to one year
Title
Change in Carcinoembryonic antigen
Time Frame
Postoperative up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Rosemurgy, MD
Organizational Affiliation
Florida Hospital Tampa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy

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