Radiofrequency Splanchnic Denervation ,neurolytic Retrocrural Celiac Plexus Block Chronic Upper Abdominal Cancer Pain

NCT06678061 | Completed DMC FDA Device

• 1 other identifier: ERSDCNRCPBPCUACP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

To compare between the efficacy of radiofrequency splanchnic denervation and neurolytic retrocrural celiac plexus block in chronic upper abdominal cancer pain

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• the Numeric Pain Rating Scale (NRS) pain scale

  Change in the Numeric Pain Rating Scale (NRS) pain scale at the first 2 weeks compared to the pre-procedural pain

  6 months

Secondary Outcomes (3)

• 1- Total opioid consumption

  6 months

• Functional Assessment of Chronic Illness Therapy or Cancer Therapy (FACT)

  6 months

• Patient Health Questionnaire (PHQ-9)

  6 months

Study Arms (2)

radiofrequency splanchnic denervation

ACTIVE COMPARATOR

Radiofrequency ablation of splenic nerve. The nerves were then anesthetized with 2 mL of 2% lidocaine before RF performed. In RFA group, lesion will be performed at 80 degrees celsius for 3 lesions 2 minutes each on both sides.

Device: radiofrequency

Celiac plexuc block

ACTIVE COMPARATOR

Neurolytic ablation of the celiac plexus.Two milliliter of contrast material will be injected in each side for confirmation a test injection with 5 mL of 2% lidocaine to both sides, and wait for 5 minutes then inject 5 ml of 100% alcohol will in each side after 5 minutes to allow the local anesthetic to take action. 1 ml of 2%

Device: radiofrequency

Interventions

radiofrequency DEVICE

block of neurolytic retrocrural celiac plexus block

Also known as: plexus block

Celiac plexuc block; radiofrequency splanchnic denervation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 20-70 years old, with upper GIT tumors, including cancer of the lower third of the esophagus, stomach cancer, pancreatic cancer, cancer liver, and cancer of the biliary tract,
• Abdominal cancer pain: includes patients with NRS pain score ≥ 5. \[16\]
• Included participants should show adequate response to diagnostic block for the splanchnic nerves, i.e. reduction of NRS pain score \> 50% at least for 2 hours

You may not qualify if:

• \- a- Patient's refusal. b- Patients medical condition as: coagulopathies, moderate or major cardiac/respiratory incapacitating diseases, liver or renal failure, infection either systemic or localized and anatomical anomalies or lesions at the spine.
• c- Any psychiatric illness that would interfere with the perception and the assessment of pain, and any reason that would result in the protocol violation

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

South Egypt Cancer Institute

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (6)

• Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. doi: 10.1007/s11606-007-0333-y. Epub 2007 Sep 14.

  PMID: 17874169 BACKGROUND

• Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

  PMID: 18388841 BACKGROUND

• Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.

  PMID: 11331334 BACKGROUND

• Miguel R. Interventional treatment of cancer pain: the fourth step in the World Health Organization analgesic ladder? Cancer Control. 2000 Mar-Apr;7(2):149-56. doi: 10.1177/107327480000700205.

  PMID: 10783819 BACKGROUND

• Peipert JD, Cella D. Bifactor analysis confirmation of the factorial structure of the Functional Assessment of Cancer Therapy-General (FACT-G). Psychooncology. 2019 May;28(5):1149-1152. doi: 10.1002/pon.5062. Epub 2019 Apr 17. No abstract available.

  PMID: 30883962 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Dr. Samy Erfan, MD

  AssiutUniversity

  STUDY DIRECTOR

• Nourhan Elgallay, Msc

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPLE INVESTIGATOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)