Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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 .

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03770247
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mansoura University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tarek M. Shams, MDMahmoud M. Elsedeiq, MScMohamed A. Ghanim, MDIbrahim I. Abd El-basir, MD
Principal Investigator Affiliation	: Professor of Anesthesia and Surgical Intensive Careassistan lecturer of Anesthesia and Surgical Intensive CareAssistant Professor of Anesthesia and Surgical Intensive CareLecturer of Anesthesia and Surgical Intensive Care
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain, Chronic

Additional Details

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 .

Arms & Interventions

Arms

Experimental: intraoperative group (IOCPN group)

Intraoperative celiac plexus neurolysis Before closure of the abdomen the surgeon will expose the aorta at the level of the celiac trunk.With the stomach retracted inferiorly, the index and second finger of the surgeon's left hand straddle the aorta with the index finger placed on the splenic artery and the second finger on the common hepatic artery. we will use of a 20- gauge spinal needle (in contrast to the usual short intravenous needle) allows better visualization and access to this area, especially in deep patients, while a 10 ml syringe permits the surgeon to control the injection with the right hand alone.(10) Twenty ml of 90 % alcohol, five ml lidocaine 2%, five mg dexamethasone will be injected in each side of the aorta after aspiration to exclude intravascular or subarachnoid injection.

Active Comparator: CT group (CTCPN group)

CT guided celiac plexus neurolysis After one week of the operation and the patient completely awake, the patient will be transferred to CT lab. The procedure will be done after attachment of basic monitors and transfusion of 500 ml saline in 20 G cannula before starting the procedure and the patient will be given 5 mg midazolam as a sedation. The procedure will be done by anesthetist and radiologist who had a good experience in celiac plexus neurolysis. In our study we will use the classic posterior bilateral approach. The patient will be in the prone position. After sterilization of the back by chlorohixidine 10 % , subcutaneous injection of 5 ml lidocaine as a local anaesthesia until a wheel will be formed then the procedure will be done. We will use 20 G Chiba needle under guidance of CT. Twenty ml of 95% alcohol , five ml lidocaine 2 % and five mg dexamethasone in each side of the aorta after aspiaration to exclude intravascular injection and subarachnoid injection

Interventions

Procedure: - Intraoperative celiac plexus neurolysis

neurolysis of celiac plexus by intraoperative techniques

Procedure: - CT guided celiac plexus neurolysis

Neurolysis of celiac plexus percutaneously by CT guidance

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International Sites

Mansourah, Dakahlia, Egypt

Status

Recruiting

Address

Mansoura university , gastrointestinal surgery center

Mansourah, Dakahlia,

Site Contact

Mahmoud M. Elsedeiq, MSc

mahmoudelsedeik1987@yahoo.com

01095378336 #002

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