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Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy

NCT02575014 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-02-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Florida Hospital Tampa Bay Division

    lead OTHER

Principal Investigators

  • Alexander S Rosemurgy, MD · Florida Hospital Tampa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575014 on ClinicalTrials.gov