Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3in Palmar Hyperhidrosis.

NCT ID: NCT03506828

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-01-02

Brief Summary

Primary hyperhidrosis is a disorder characterized by excessive and chronic sweating in the absence of a sweating trigger. The disorder can be severe and interfere with normal daily activities of the patients.

The gold-standard treatment in severe cases of hyperhidrosis is thoracoscopic sympathectomy betweenT2 and T4. These procedures are regularly performed in surgical units under general anaesthesia which needs special anesthetic considerations which is complex and associated with a lot of complications.

Radiofrequency ablation of the sympathetic chain for treatment of hyperhidrosis is considered alternative to thoracoscopic sympathectomy. The procedure is safe, inexpensive and done under sedation with local anaesthesia in an outpatient setting, but its success rate is still significantly lower than endoscopic sympathectomy.

The purpose of this study is to determine whether adding phenol 6% in a mixture with glycerin will increase the efficacy of fluoroscopy guided radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis in comparison to surgery without significant side effects to provide safe and effective method rather than surgery.

Detailed Description

Primary hyperhidrosis is a disorder characterized by excessive, chronic sweating in the absence of a sweating trigger. This condition must be differentiated from secondary hyperhidrosis, which is due to a lot of stimuli as infection, malignancy, drugs, anxiety, neurological and endocrine disorders.

Primary hyperhidrosis is caused by hyperactivity of the sympathetic system. The etiology of the disease is unknown and appears simultaneously. It affects patients between 15 and 40 years of age and may cause serious damage to their quality of life.

The first line of treatment of hyperhidrosis is non-surgical methods as topical antiperspirants, anti-cholinergic and Botox, but the disadvantages of this treatment are short term relieve, so repetition of this treatment is required.

Thoracoscopic Sympathectomy of the sympathetic chain between T2 and T4 is considered the gold-standard treatment in severe cases of hyperhidrosis. These procedures are performed in surgical units under general anaesthesia which needs special anesthetic considerations in the form of double lumen tube and one lung ventilation.

Complications like pneumothorax, surgical emphysema, lung injury, lobar collapse, atelectasis, pleural effusion; bleeding, Horner's syndrome and neuritis have been described. Postoperative pain is more severe which can occasionally require opiate analgesia.

Radiofrequency ablation of the sympathetic chain is considered alternative to thoracoscopic sympathectomy for hyperhidrosis. The procedure is safe, inexpensive and done under sedation with local anaesthesia in an outpatient setting, but its success rate is still significantly lower than endoscopic sympathectomy.

McCormack et al. concluded that there are anatomical variations in the position of sympathetic trunk which are thought to be one of the main causes of failure and patient dissatisfaction after thoracic sympathetic neurolysis in hyperhidrosis.

Previous studies tried to increase the efficacy of radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis via adding alcohol 100% to cover the anatomical variations of the sympathetic trunk. Alcohol is intensely painful during injection, so large volume of local anaesthetics is injected prior to alcohol. Also, it is hypobaric, water soluble and spread rapidly from the injection site, so large volume is required. In addition, the incidence of neuritis is very high with its injection.

Phenol is primarily a local anesthetic at lower concentrations and becomes more neurolytic at higher concentration. Unlike alcohol, it is not painful on injection. It is prepared in a mixture with glycerin so it is highly soluble and hyperbaric and diffuses slowly into the local tissues.

In this study, the effect of adding phenol 6% with percutaneous fluoroscopy guided radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis will be evaluated. The study hypothesizes that adding phenol 6% in a mixture with glycerin will increase the efficacy of radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis in comparison to surgery without significant side effects to provide safe and effective method rather than surgery for hyperhidrosis.

Conditions

Excessive Sweating of the Hands

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical sympathectomy

All patients in this group will have standard surgical procedure

Group Type: ACTIVE_COMPARATOR

Surgical sympathectomy

Intervention Type: PROCEDURE

thoracoscopic sympathectomy

Radiofrequency ablation with phenol injection

patient will receive radiofrequency ablation of T2 and T3 sympathetic ganglia + phenol 6% (0.5ml) injection

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation with phenol injection

Intervention Type: PROCEDURE

All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection

Interventions

Surgical sympathectomy

thoracoscopic sympathectomy

Intervention Type: PROCEDURE

Radiofrequency ablation with phenol injection

All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status grades I and II

Exclusion Criteria

• Patient refusal.
• Hepatic impairement.
• Renal impairment.
• Neuromuscular diseases.
• History of opioid abuse.
• Coagulopathies.
• Cardiovascular diseases.
• Respiratory diseases.
• Previously failed cases either after percutaneous or thoracoscopic sympathectomy.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gamal M El Morsy, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive Care

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MFM-IRB, MD/17.11.08

Identifier Type: -

Identifier Source: org_study_id