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EUS-guided CGN for Inoperable Cancer

Primary Purpose

Intractable Abdominal Pain Secondary to Inoperable Malignancy

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
EUS-guided celiac ganglion neurolysis
Percutaneous celiac plexus neurolysis
Olympus UM 2000
B-D Quincke Type Point
Levobupivacaine
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intractable Abdominal Pain Secondary to Inoperable Malignancy focused on measuring Celiac plexus neurolysis, Celiac ganglion neurolysis, Pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-guided celiac ganglion neurolysis

Percutaneous celiac plexus neurolysis

Arm Description

Endoscopic ultrasound guided celiac ganglion neurolysis would be performed

Percutaneous celiac plexus neurolysis would be performed

Outcomes

Primary Outcome Measures

Pain score measured using the visual analogue scale
Pain scores at 2 weeks after the procedure will be measured using the visual analogue scale

Secondary Outcome Measures

Opioid requirements (Amounts of opioid medications required at assessment interval)
Amounts of opioid medications required at assessment interval
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.
Quality of life scores (FACT-Hep Chinese module)
QOL would be assessed using the FACT-Hep Chinese module

Full Information

First Posted
August 20, 2014
Last Updated
January 29, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02356640
Brief Title
EUS-guided CGN for Inoperable Cancer
Official Title
A Randomized Controlled Trial on Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Percutaneous Celiac Plexus Neurolysis in Patients With Inoperable Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 29, 2019 (Actual)
Study Completion Date
January 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Abdominal Pain Secondary to Inoperable Malignancy
Keywords
Celiac plexus neurolysis, Celiac ganglion neurolysis, Pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided celiac ganglion neurolysis
Arm Type
Active Comparator
Arm Description
Endoscopic ultrasound guided celiac ganglion neurolysis would be performed
Arm Title
Percutaneous celiac plexus neurolysis
Arm Type
Active Comparator
Arm Description
Percutaneous celiac plexus neurolysis would be performed
Intervention Type
Procedure
Intervention Name(s)
EUS-guided celiac ganglion neurolysis
Intervention Description
EUS-CGN would be performed with a linear video echoendoscope (Olympus UM 2000; Olympus Co Ltd, Japan). The celiac ganglia are visualized under linear EUS and the injection would be applied directly into the ganglia. It is represented by small 2 to 3 mm hypoechoic nodules with hyperechoic foci in the center or a single elongated hypoechoic structure. IIf the ganglia are not identified by EUS, then injection would be performed as bilateral injections at the celiac vessel trunk. All procedures would be performed by a two experienced endosonographer.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous celiac plexus neurolysis
Intervention Description
Percutaneous fluoroscopy-guided CPN would be performed in the operation theatre with the transcural technique. A 22-gauge, 17 cm-long spinal needle (B-D Quincke Type Point, Becton Dickinson &Co., NJ 07417, USA) would be inserted and advanced just caudal to the margin of 12th rib and cephalad to the transverse process of L1 toward the anterolateral surface of the L1 vertebral body. Final needle position would be confirmed by radiographic contrast, layering over anterior surface of aorta. 10mL of levobupivacaine (0.25%), followed by 10mL of absolute alcohol would be injected on both sides using separate punctures.
Intervention Type
Device
Intervention Name(s)
Olympus UM 2000
Intervention Type
Device
Intervention Name(s)
B-D Quincke Type Point
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Primary Outcome Measure Information:
Title
Pain score measured using the visual analogue scale
Description
Pain scores at 2 weeks after the procedure will be measured using the visual analogue scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Opioid requirements (Amounts of opioid medications required at assessment interval)
Description
Amounts of opioid medications required at assessment interval
Time Frame
2 weeks then monthly for 1 yr or till death
Title
Adverse events
Description
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.
Time Frame
2 weeks, then monthly for 1 yr or till death
Title
Quality of life scores (FACT-Hep Chinese module)
Description
QOL would be assessed using the FACT-Hep Chinese module
Time Frame
2 week, then monthly for 1 yr or till death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients ≥ 18 years old with cytology or histology confirmed pancreatic cancer, or radiologically suggestive of pancreatic cancer ( for patients whom biopsy is impossible) 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) Inoperability of cancer as demonstrated by EUS, computed tomography (CT) or Positive emission tomography Informed consent available Exclusion Criteria: Unable to safely undergo EUS for any reason Patient is unable to lie prone for procedure Coagulopathy (prolongation of prothrombin time > 18 sec) or thrombocytopenia <80,000 platelets/ml) Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder Allergy to local anaesthesia, contrast, or alcohol Potential patient noncompliance (refusing to follow schedule of events) Active alcohol or other drug use or significant psychiatric illness Expected survival less than 6 weeks
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21844506
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.
Results Reference
background
PubMed Identifier
17970834
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. doi: 10.1111/j.1572-0241.2007.01607.x. Epub 2007 Oct 26.
Results Reference
background
PubMed Identifier
23616126
Citation
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.
Results Reference
background

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EUS-guided CGN for Inoperable Cancer

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