Clinical trial NCT03770247: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

Eligibility criteria: Inclusion Criteria:

* Adult patients suffering of pain from pancreatic cancer with baseline VAS≥5, scheduled for surgical assessment
* patients proven histololgically to be unresectable
* patients undergoing either biopsy or bypass surgery

Exclusion Criteria:

* patient with resectable tumour will be excluded.
* Patient with coagulopathy.
* patient with aortic aneurysm.
* patient with any disease contraindicating any sympathetic blockade as advanced cardiac disease .

Primary outcomes:
measure: assesment of efficacy in pain palliation by change in VAS after one month
timeFrame: one month
Secondary outcomes:
measure: incidence of complication
timeFrame: one month
measure: total analgesic consumption
timeFrame: 6 month
measure: duration of pain palliation
timeFrame: 6 month
measure: need of other injection
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university , gastrointestinal surgery center
state: Dakahlia
Study officials:
affiliation: : Professor of Anesthesia and Surgical Intensive Care
name: Tarek M. Shams, MD
role: STUDY_DIRECTOR
affiliation: assistan lecturer of Anesthesia and Surgical Intensive Care
name: Mahmoud M. Elsedeiq, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Mohamed A. Ghanim, MD
role: STUDY_CHAIR
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Ibrahim I. Abd El-basir, MD
role: STUDY_CHAIR
References: