- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2014-08
2019-01-29
2019-01-29
3
NCT02356640
Chinese University of Hong Kong
Chinese University of Hong Kong
INTERVENTIONAL
EUS-guided CGN for Inoperable Cancer
Patients suffering from pancreatic cancer are associated with a poor prognosis and survival of less than one year is expected in inoperable tumours. Management of these patients would be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this "intractable" pain is often difficult to treat. Different pharmacological agents have been used in the past to control this pain and these include non-steroidal anti-inflammatory drugs and narcotic agents. However, patients' responses are often variable and difficult to predict. Furthermore, these agents are associated with their own adverse effects and may further impair quality of life. Celiac plexus neurolysis (CPN) was first described in 1919, since then, different approaches of performing the procedure have been described. The standard technique involves a percutaneous approach but CPN can also be performed by an intra-operative approach with open or laparoscopic means. Results from meta-analysis have shown that CPN was associated with superior pain relief as compared to analgesic therapy alone and reduces the need for opioids analgesics in patients with inoperable pancreatic cancer. Furthermore, CPN causes fewer adverse effects than opioid analgesics and it is the preferred method of improving pain relief in these patients. Recently, endoscopic ultrasonography (EUS) - guided CPN has become popular. The approach is safe and effective and was shown to be associated with long lasting pain relieve in patients suffering from chronic pancreatitis or pancreatic cancer. Serious complications are uncommon and are less than 2% in these series. Transient diarrhoea and hypotension are common after CPN and is seen up to 30% to 40% of the patients, regardless of whether the procedure is being done by the EUS or percutaneous approach. The EUS approach offers several theoretical advantages over the percutaneous option. Most notably is the visualization of the celiac ganglia situated anterior to the aorta, allowing direct injection of the ganglia with alcohol resulting in celiac ganglion neurolysis (CGN). This increases the accuracy of CPN and may result in improved pain control. Furthermore, it could reduce complications associated with the percutaneous approach that includes lower extremity paresthesia and paralysis. Hence, the aim of the study is to compare the efficacy and safety of endoscopic ultrasound (EUS)-guided celiac ganglion neurolysis (CGN) versus percutaneous celiac plexus neurolysis (CPN) in reducing cancer pain in patients suffering from inoperable cancer. With direct visualization and injection of the celiac ganglion, the investigators hypothesis that EUS-guided CGN is more advantageous on improving pain relief and decreasing the need for opioid analgesics in patients with inoperable cancer as compared to percutaneous CPN.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-08-20 | N/A | 2019-01-29 |
2015-02-04 | N/A | 2019-01-30 |
2015-02-05 | N/A | 2019-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: EUS-guided celiac ganglion neurolysis Endoscopic ultrasound guided celiac ganglion neurolysis would be performed | PROCEDURE: EUS-guided celiac ganglion neurolysis
DEVICE: Olympus UM 2000 |
| ACTIVE_COMPARATOR: Percutaneous celiac plexus neurolysis Percutaneous celiac plexus neurolysis would be performed | PROCEDURE: Percutaneous celiac plexus neurolysis
DEVICE: B-D Quincke Type Point DRUG: Levobupivacaine |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pain score measured using the visual analogue scale | Pain scores at 2 weeks after the procedure will be measured using the visual analogue scale | 2 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Opioid requirements (Amounts of opioid medications required at assessment interval) | Amounts of opioid medications required at assessment interval | 2 weeks then monthly for 1 yr or till death |
| Adverse events | Patients would be monitored for presence of adverse events after CGN or CPN. Transient diarrhea and hypotension are common manifestations of the sympathetic blockade and may be seen in up to 38 and 44 percent of the patients. Severe adverse effects after percutaneous CPN include neurologic complications (l%) such as lower extremity weakness and paresthesia, epidural anesthesia, and lumbar puncture. Non-neurological adverse effects (1%) including pneumothorax, shoulder, chest and pleuritic pain, hiccoughing, and hematuria have also been reported. | 2 weeks, then monthly for 1 yr or till death |
| Quality of life scores (FACT-Hep Chinese module) | QOL would be assessed using the FACT-Hep Chinese module | 2 week, then monthly for 1 yr or till death |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
