Intractable Abdominal Pain Secondary to Inoperable Malignancy Clinical Trial
Official title:
A Randomized Controlled Trial on Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Percutaneous Celiac Plexus Neurolysis in Patients With Inoperable Cancer
| Verified date | January 2019 |
| Source | Chinese University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | January 29, 2019 |
| Est. primary completion date | January 29, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. All patients = 18 years old with cytology or histology confirmed pancreatic cancer, or radiologically suggestive of pancreatic cancer ( for patients whom biopsy is impossible) 2. Pain associated with inoperable cancer ( including abdominal pain or back pain, managed according to WHO analgesic ladder, with VAS score =4 despite simple analgesics (first 2 steps of WHO analgesic ladder) 3. Inoperability of cancer as demonstrated by EUS, computed tomography (CT) or Positive emission tomography 4. Informed consent available Exclusion Criteria: 1. Unable to safely undergo EUS for any reason 2. Patient is unable to lie prone for procedure 3. Coagulopathy (prolongation of prothrombin time > 18 sec) or thrombocytopenia <80,000 platelets/ml) 4. Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy 5. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder 6. Allergy to local anaesthesia, contrast, or alcohol 7. Potential patient noncompliance (refusing to follow schedule of events) 8. Active alcohol or other drug use or significant psychiatric illness 9. Expected survival less than 6 weeks |
| Country | Name | City | State |
|---|---|---|---|
| China | Chinese University of Hong Kong | Hong Kong | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong |
China,
Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24. — View Citation
Levy MJ, Topazian MD, Wiersema MJ, Clain JE, Rajan E, Wang KK, de la Mora JG, Gleeson FC, Pearson RK, Pelaez MC, Petersen BT, Vege SS, Chari ST. Initial evaluation of the efficacy and safety of endoscopic ultrasound-guided direct Ganglia neurolysis and block. Am J Gastroenterol. 2008 Jan;103(1):98-103. Epub 2007 Oct 26. — View Citation
Wyse JM, Carone M, Paquin SC, Usatii M, Sahai AV. Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. J Clin Oncol. 2011 Sep 10;29(26):3541-6. doi: 10.1200/JCO.2010.32.2750. Epub 2011 Aug 15. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |