Palliative Care Outcomes in the Management of Malignant A... | NCT02477657

Studies
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

NCT02477657

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Withdrawn

Last Update Posted

Jan 12, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Refractory Malignant Ascites

Interventions

Paracentesis
Tunneled Intraperitoneal Drain (IPD)
Peritoneal-Venous shunts (PVS)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Industry funding not received. No subjects enrolled.

Expanded Access Info

Start Date

Jul 2021Estimated

Primary Completion Date

Jul 2022Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 18, 2015

First Posted Date

Jun 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2022

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Paracentesis	Procedure	Paracentesis
Tunneled Intraperitoneal Drain (IPD)	Device	Tunneled Intraperitoneal Drain (IPD)
Peritoneal-Venous shunts (PVS)	Device	Peritoneal-Venous shunts (PVS)

Measure	Description	Time Frame
Number of Adverse Events		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR
Known malignancy with imaging findings of peritoneal carcinomatosis .
Eastern Cooperative Oncology Group (ECOG) performance score 3
Age greater than or equal to 18
Capable of giving informed consent

Exclusion Criteria:

Life expectancy less than one month
Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
Active skin infections at sites where PVS would be inserted
Presence of infectious peritonitis or bacteremia
Neutropenia
American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV)
Stage 5 CKD (ie GFR < 15 mL/min)
Severe hypoalbuminemia defined as < 2.2 g/dL
Loculated or hemorrhagic ascites
History of bleeding gastroesophageal varices
Inability to provide informed consent
Unable to participate in neuropsychological tests / questionnaires
Pregnant or nursing women
Anasarca

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with refractory malignant ascites secondary to GU or GI malignancy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Nadolski, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis