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Completed

NCT Number: NCT03770247

Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

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

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university , gastrointestinal surgery center

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Intraoperative celiac plexus neurolysis

Procedure

neurolysis of celiac plexus by intraoperative techniques

CT guided celiac plexus neurolysis

Procedure

Neurolysis of celiac plexus percutaneously by CT guidance

Primary outcomes

  1. assesment of efficacy in pain palliation by change in VAS after one month

    Time frame: 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

Secondary outcomes

  1. incidence of complication

    Time frame: one month

    report the occurrence of complication as headache , diarrhea , vomiting , back pain

  2. total analgesic consumption

    Time frame: 6 month

    the amount of analgesic required

  3. duration of pain palliation

    Time frame: 6 month

    change of visual analogue scale from baseline for 6 months visual analogue scale represent pain from 0 no pain to 10 maximum pain

  4. need of other injection

    Time frame: 6 months

    if failure of intervention occured patient may need another intervention

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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