Radiofrequency and Chemical Neurolysis of Thoracic Splanc... | NCT03063112

Studies
Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain

NCT03063112

Sponsor

South Egypt Cancer Institute

Status

Unknown status

Last Update Posted

Feb 28, 2017Actual

Enrollment

79Estimated

Phase

Not Applicable

Conditions

Abdominal Cancer

Interventions

Radiofrequency generator device
Lidocaine
C arm fluoroscopic device
Ethyl alcohol

Countries

Egypt

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Apr 10, 2017Estimated

Completion Date

May 1, 2017Estimated

First Submitted Date

Feb 10, 2017

First Submission Date that Met QC Criteria

Feb 23, 2017

First Posted Date

Feb 24, 2017Actual

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

Feb 26, 2017

Last Update Posted Date

Feb 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fatma Al Zahraa Hamed Abdel Hameed, Lecturer of anasthesia and pain relief, South Egypt Cancer InstitutePrincipal Investigator

Lead Sponsor

South Egypt Cancer InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer.

Detailed Description

Radiofrequency thermocoagulation of splanchnic nerves was done bilaterally at level of thoracic vertebra T10 and T11 ( there were no enough studies done to test the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of splanchnic nerves at level of T10 ). Aim of the Study is to compare between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of bilateral thoracic splanchnic nerves at level T10 and T11 vertebra and chemical neurolytic block of them at level of T11 vertebra only in the management of upper abdominal cancer pain.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1( radiofrequency group )	Active Comparator	Bilateral thoracic splanchnic nerves block will be performed by radiofrequency thermocoagulation at two level of vertebra T10 and T11 by using radiofrequency generator device and lidocaine 2% before thermal lesion	Device: Radiofrequency generator device Drug: Lidocaine
Group 2 ( alcohol group )	Placebo Comparator	Bilateral thoracic splanchnic nerves block will be performed by ethyl alcohol at one level of vertebraT11 by using of C arm fluoroscopic device.	Device: C arm fluoroscopic device Drug: Ethyl alcohol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency generator device	Device	sympathetic blockade or ablation of thoracic splanchnic nerves	Group 1( radiofrequency group )

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain relief	Visual analogue pain scale	3 months

Secondary Outcomes

Measure	Description	Time Frame
Decrease the need for analgesic drugs	Reduction of total oral morphine consumption dose in mg per day	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients suffering from upper abdominal cancer pain.
Visceral pain with visual analogue pain score ≥ 4.
Normal coagulation profile.
Positive diagnostic test.
Written informed consent from the patients .

Exclusion Criteria:

Patients with organ failure.
Coagulation disorders.
Local infection at the puncture site or sepsis.
Allergy to the contrast dye or alcohol.
Severe displacement of intra-abdominal structures.
Pregnant women.
Documented metastatic lesions.
Psychiatric illness affecting cooperation.
De-compensated cardiac disorders.
Liver and renal dysfunction.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatma Al Zahraa H Abdel Hameed, Lecturer	Contact	0201063684819		drfatmahamed15@gmail.com
Ahmed H Othman, Professor	Contact	0201000525368		ahmadhothman@gmail.com

Overall Officials

Name	Affiliation	Role
Samy A Erfan, Professor	Head of the department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Egypt Cancer Institute	Recruiting	Asyut	Assuit Governrate	+20	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D000431	Ethanol

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided