Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication

A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies

The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.

Study Overview

• Status: Withdrawn
• Conditions: Lung Diseases; Mesothelioma
• Intervention / Treatment: Other: Progel Sealant; Behavioral: Pain Questionnaire; Other: Talcum Powder

Detailed Description

If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.

At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.

Then, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:

• One group will have Progel® added to the surface of the lung before closing the chest.
• The other group will have talcum powder added to the surface of the lung before closing the chest.

Participant will have an equal chance of being in either group.

During the surgery, air leaks will be checked electronically and that information will be recorded.

After surgery, participant will be asked to rate their pain on a pain scale of 0-10. Participant will be asked to complete this pain scale 3 times each day while they are in the hospital.

Length of Study Participation:

After participant's surgery and their air leak is resolved, their participation in this study will be over.

This is an investigational study. The Progel® surgical sealant is FDA approved for the control of air leaks during lung surgery. It is investigational to compare the surgical sealant with the standard-of-care (talcum powder) to learn if it can reduce the number of days in the hospital after surgery.

Up to 48 participants will enrolled in this study. All will take part at MD Anderson.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center
2. Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min

Exclusion Criteria:

1. Patients unable to consent for the procedure
2. Patients with a history of allergy to human proteins
3. Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Progel Sealant; After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.	Other: Progel Sealant; After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.; Behavioral: Pain Questionnaire; Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.; Other Names: Survey
ACTIVE_COMPARATOR: Standard of Care; After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.	Behavioral: Pain Questionnaire; Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.; Other Names: Survey; Other: Talcum Powder; After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Resolve Air Lung Leak After Pleurectomy Decortication	Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.	Participants followed for the duration of hospital stay, at least 5 days.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Bard Incorporated
• Investigators: Principal Investigator: Reza J. Mehran, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (ESTIMATE): July 30, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Lung Diseases; Surveys; Mesothelioma; Talcum powder; Pleurectomy decortication; Progel; Pain questionnaires; Intraoperative air leaks; IAL
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Lung Diseases; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: 2014-0958; NCI-2015-01511 (REGISTRY: NCI CTRP)