Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Pain

Gastrointestinal Neoplasms

Celiac Disease

Digestive System Neoplasms

Gastrointestinal Diseases

Quality of Life

The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial.

All eligible patients will receive the same protocol of celiac plexus radiosurgery

5 fractions of SBRT (Stereotactic body radiation therapy). The target will always include the anterior-medial aspect aorta at T12-L2 (surrogate for celiac plexus). If there is adjacent tumor (e.g. pancreatic tumor that infiltrates the celiac plexus) this will be irradiated in addition.

It is expected that patients will be treated with a rapid-arc IMRT (Intensity modulation radiation therapy) dose-painting technique. Details of beam arrangement and energy used will be determined on an individual basis.

Celiac Plexus Radiosurgery

David Hausner, M.D

Yaacov R Lawrence, MBBS MA MRCP

This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment.

The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment.

The treatment duration is one and a half weeks (5 fractions delivered every other weekday).

Celiac Plexus Radiosurgery for Pain Management

Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial

Average analgesic consumption will be defined using daily oral morphine equivalents in milligrams

The safety profile will focused on fatigue and expected GI (gastro-intestinal) toxicities as nausea, vomiting and diarrhea. Acute and late toxicity will be assessed using the NCI-CTCAE (common toxicity criteria for adverse events) version 4.0

Sheba Medical Center

palliative care physician

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Pancreatic Neoplasms

Ganglion Cysts

Cancer Pain

Synovial Cyst

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Neurologic Manifestations

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

* Hypothesis:

  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
* Rationale:

  * Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.

EUS Guided Celiac Neurolysis

Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain

American College of Gastroenterology

Mayo Clinic

Professor of Medicine

Abdominal Pain

Signs and Symptoms, Digestive

All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.

Cryoablation

David D Childs, MD

CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.

CUC10-PAN09 is a Supportive Care, Phase 1 multicenter, prospective, single arm study with subjects serving as their own control. This study is to enroll patients who will undergo cryoablation of the Celiac Plexus. Subjects will be followed for 3 months post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer

Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer

Measured by the average difference of pre- and post-treatment worst pain in the last 24 hours (baseline), within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory (BPI) Scale

Measured from the cryoablation procedure to the return of the abdominal pain

Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation

Measured from baseline to within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory Scale

Measured from baseline to within 24 hours of the cryoablation procedure, 4, 8 and 12 weeks post cryoablation procedure

The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure

Measured worst pain score in the 12 week follow-up period as measured on a numeric 0-10 Brief Pain Inventory Scale

Subjects will answer questions regarding their satisfaction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Celiac Plexus Radiosurgery for Pain Management	NCT02356406	Digestive Syste...	Celiac Plexus R...	18 Years -	Sheba Medical Center
EUS Guided Celiac Neurolysis	NCT01615653	Pancreatic Canc...	EUS	-	Mayo Clinic
Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer	NCT01335945	Pain Pancreatic Canc...	Cryoablation	18 Years -	Boston Scientific Corporation
Celiac Plexus Radiosurgery for Pain Management	NCT02356406	Digestive Syste...	Celiac Plexus R...	18 Years -	Sheba Medical Center

Spots Global Cancer Trial Database for celiac plexus