Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770247
• Other study ID #: MD / 17.08.53
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Procedure:
• Intraoperative celiac plexus neurolysis
neurolysis of celiac plexus by intraoperative techniques
• CT guided celiac plexus neurolysis
Neurolysis of celiac plexus percutaneously by CT guidance

Locations

Country	Name	City	State
Egypt	Mansoura university , gastrointestinal surgery center	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assesment of efficacy in pain palliation by change in VAS after one month	change in visual analogue scale ( VAS) after one month visual analogue scale is pain scale from 0 to 10 , 0 no pain , 10 maximum pain lower VAS better than higher .a positive responce defined as decrease of VAS of equal or more than 3	one month
Secondary	incidence of complication	report the occurrence of complication as headache , diarrhea , vomiting , back pain	one month
Secondary	total analgesic consumption	the amount of analgesic required	6 month
Secondary	duration of pain palliation	change of visual analogue scale from baseline for 6 months visual analogue scale represent pain from 0 no pain to 10 maximum pain	6 month
Secondary	need of other injection	if failure of intervention occured patient may need another intervention	6 months