Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy

NCT02575014 | Unknown DMC

• 1 other identifier: HBOT 529762
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periampullary Tumor; Common Bile Duct Neoplasms; Duodenal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  Preoperative

Secondary Outcomes (13)

• Death

  Postoperative up to 5 years

• Length of hospital stay

  Postoperative up to one month

• Postoperative complications

  Postoperative up to one month

• Change in Interleukin-2

  Postoperative up to one month

• Change in Interleukin-6

  Postoperative up to one month

Study Arms (2)

Preoperative HBOT

EXPERIMENTAL

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

No HBOT

NO INTERVENTION

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

Interventions

Preoperative hyperbaric oxygen DRUG

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.

Also known as: O2

Preoperative HBOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida Hospital Tampa Bay Division: lead

Study Sites (1)

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Common Bile Duct Neoplasms; Duodenal Neoplasms

Condition Hierarchy (Ancestors)

Bile Duct Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Study Officials

• Alexander S Rosemurgy, MD

  Florida Hospital Tampa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgical Digestive Disorders and GERD Center, Director HPB Surgery and Fellowship Program

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2022
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)