Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

NCT03770247 | Completed DMC

• 1 other identifier: MD ∕ 17.08.53
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective treatment method of pain associated with pancreatic cancer. The neurolytic injectate is usually alcohol 50-100%; however, phenol \>5% is also possible to use. Nowadays, there are several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous computed tomography guided technique is the gold standard technique, it has multiple drawbacks as availability and cost of imaging modality, exposure to radiation and multiple complications.Surgical technique in spite of being easy, cheap but there is a controversy about its efficacy. Also there is no head to head comparison between the surgical technique and the percutaneous technique.In this study we hypothesized that intraoperative technique has the same efficacy of percutaneous celiac block technique with less complication and cost

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• assesment of efficacy in pain palliation by change in VAS after one month

  change in visual analogue scale ( VAS) after one month visual analogue scale is pain scale from 0 to 10 , 0 no pain , 10 maximum pain lower VAS better than higher .a positive responce defined as decrease of VAS of equal or more than 3

  one month

Secondary Outcomes (4)

• incidence of complication

  one month

• total analgesic consumption

  6 month

• duration of pain palliation

  6 month

• need of other injection

  6 months

Study Arms (2)

intraoperative group (IOCPN group)

EXPERIMENTAL

Intraoperative celiac plexus neurolysis Before closure of the abdomen the surgeon will expose the aorta at the level of the celiac trunk.With the stomach retracted inferiorly, the index and second finger of the surgeon's left hand straddle the aorta with the index finger placed on the splenic artery and the second finger on the common hepatic artery. we will use of a 20- gauge spinal needle (in contrast to the usual short intravenous needle) allows better visualization and access to this area, especially in deep patients, while a 10 ml syringe permits the surgeon to control the injection with the right hand alone.(10) Twenty ml of 90 % alcohol, five ml lidocaine 2%, five mg dexamethasone will be injected in each side of the aorta after aspiration to exclude intravascular or subarachnoid injection.

Procedure: Intraoperative celiac plexus neurolysis

CT group (CTCPN group)

ACTIVE COMPARATOR

CT guided celiac plexus neurolysis After one week of the operation and the patient completely awake, the patient will be transferred to CT lab. The procedure will be done after attachment of basic monitors and transfusion of 500 ml saline in 20 G cannula before starting the procedure and the patient will be given 5 mg midazolam as a sedation. The procedure will be done by anesthetist and radiologist who had a good experience in celiac plexus neurolysis. In our study we will use the classic posterior bilateral approach. The patient will be in the prone position. After sterilization of the back by chlorohixidine 10 % , subcutaneous injection of 5 ml lidocaine as a local anaesthesia until a wheel will be formed then the procedure will be done. We will use 20 G Chiba needle under guidance of CT. Twenty ml of 95% alcohol , five ml lidocaine 2 % and five mg dexamethasone in each side of the aorta after aspiaration to exclude intravascular injection and subarachnoid injection

Procedure: CT guided celiac plexus neurolysis

Interventions

Intraoperative celiac plexus neurolysis PROCEDURE

neurolysis of celiac plexus by intraoperative techniques

intraoperative group (IOCPN group)

CT guided celiac plexus neurolysis PROCEDURE

Neurolysis of celiac plexus percutaneously by CT guidance

CT group (CTCPN group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients suffering of pain from pancreatic cancer with baseline VAS≥5, scheduled for surgical assessment
• patients proven histololgically to be unresectable
• patients undergoing either biopsy or bypass surgery

You may not qualify if:

• patient with resectable tumour will be excluded.
• Patient with coagulopathy.
• patient with aortic aneurysm.
• patient with any disease contraindicating any sympathetic blockade as advanced cardiac disease .

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university , gastrointestinal surgery center

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tarek M. Shams, MD

  : Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

• Mahmoud M. Elsedeiq, MSc

  assistan lecturer of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

• Mohamed A. Ghanim, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Ibrahim I. Abd El-basir, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 10, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

EG (1)