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Spots Global Cancer Trial Database for Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

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Trial Identification

Brief Title: Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

Official Title: Direct Intraoperative Injection Versus Percutaneous CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer ; Randomized Controlled Study

Study ID: NCT03770247

Conditions

Pain, Chronic

Study Description

Brief Summary: Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective treatment method of pain associated with pancreatic cancer. The neurolytic injectate is usually alcohol 50-100%; however, phenol \>5% is also possible to use. Nowadays, there are several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous computed tomography guided technique is the gold standard technique, it has multiple drawbacks as availability and cost of imaging modality, exposure to radiation and multiple complications.Surgical technique in spite of being easy, cheap but there is a controversy about its efficacy. Also there is no head to head comparison between the surgical technique and the percutaneous technique.In this study we hypothesized that intraoperative technique has the same efficacy of percutaneous celiac block technique with less complication and cost

Detailed Description: This study aimed to compare the efficacy of the surgical technique versus the per cutaneous computed tomographic guided technique of celiac plexus neurolysis for pain management in unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass surgery will receive celiac plexus neurolysis either intraoperative or post operative CT guided . All patients will be managed by systemic analgesic if the block not sufficient . In this study we will give the patient the analgesic according to WHO recommendation as starting by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mansoura university , gastrointestinal surgery center, Mansourah, Dakahlia, Egypt

Contact Details

Name: Tarek M. Shams, MD

Affiliation: : Professor of Anesthesia and Surgical Intensive Care

Role: STUDY_DIRECTOR

Name: Mahmoud M. Elsedeiq, MSc

Affiliation: assistan lecturer of Anesthesia and Surgical Intensive Care

Role: PRINCIPAL_INVESTIGATOR

Name: Mohamed A. Ghanim, MD

Affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care

Role: STUDY_CHAIR

Name: Ibrahim I. Abd El-basir, MD

Affiliation: Lecturer of Anesthesia and Surgical Intensive Care

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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