Health Condition 1: C258- Malignant neoplasm of overlappingsites of pancreas Health Condition 2: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 3: C23- Malignant neoplasm of gallbladder Health Condition 4: C229- Malignant neoplasm of liver, not specified as primary or secondary Health Condition 5: C228- Malignant neoplasm of liver, primary, unspecified as to type
Conditions
Interventions
Intervention1: Celiac Plexus Neurolysis: The central approach
A 22 gauge needle will be used for puncture. It will be advanced to a point just above the origin of the celiac artery while confirming va
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age (more than 18 years) 2.Diagnosis or suspected to have unresectable pancreaticobiliary malignancy on cross-sectional imaging which is already proven or subsequently found to have confirmed malignancy on pathology either by cytology or histopathology. 3.Any level of abdominal or back pain considered to be potentially related to the mass with a score of more than or equal to 4 on an 11-point VAS with the use of Opioids to control pain. Characteristics of the pain as follows: a.New onset (less than 3 months) b.Constant c.Centrally located d.No obvious other source of pain 4.No possibility of immediate surgical management. Based on EUS/Cross sectional imaging based on arterial and venous involvement or evidence of distant metastases. Involvement of more than 50% of the circumference of the superior mesenteric vein, portal vein, or spleno-portal confluence/any involvement of superior mesenteric artery, celiac axis, or hepatic artery; or (cytologically proven nonregional lymphadenopathy 5.Patients willing to participate in the study 6.Celiac axis accessible for both unilateral and bilateral neurolysis at EUS
Exclusion criteria
Exclusion criteria: 1.Abnormal clotting (international normalized ratio more than equal to 1.5) or reduced platelet count (less than equal to 50000per micorLitre) which cannot be corrected. 2.Presence of gastric and or esophageal varices precluding the path of CPN. 3.History of prior CPN 4.Use of anticoagulation or antiplatelet agent which cannot be stopped 5.Patients with performance status ECOG 4 6. Prior upper abdominal surgery or an anatomic abnormality making endoscopic access impossible or localization of celiac plexus difficult 7.History of allergy to bupivacaine or alcohol 8.Severe cardiorespiratory illness causing procedure unsafe for the patient. 9.Patients with evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. 10.Patient with evidence of significant active infection (pneumonia, peritonitis, wound sepsis) 11.Patient with evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism) 12.Moderate to gross ascites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pain response rate on Visual analog scale score among both the groups on day 7 post Endoscopic ultrasound-guided celiac plexus neurolysis.Timepoint: DAY 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the pain response rate on Visual analog scale score among both the groups on day 30 post Endoscopic ultrasound-guided celiac plexus neurolysis.Timepoint: DAY 30;To compare the percentage pain score reduction from baseline on Visual analog scale score on day 7 and day 30.Timepoint: DAY 7 AND 30;To compare the complete pain response rates at day 7 and day 30Timepoint: DAY 7 AND 30;To compare the pain non-response rate at day 7 and day 30Timepoint: DAY 7 AND 30;To compare the intake of an opioid analgesic in terms of morphine equivalent in milligram at day 7 and day 30 compared to baselineTimepoint: DAY 7 AND 30;To compare the Incidence of adverse effects if anyTimepoint: ;The SF-36 Version-2 will be also used to assess Qulaity of living. Questionnaire responses were collected before the intervention and on day 7 and 30 after intervention.Timepoint: DAY 7 AND 30;To compare 90 days survival rate between the two groupsTimepoint: day 90;To compare Duration of pain relief: Patients with positive responses were continuously monitored every monthly to determine the duration of treatment efficacy. When the pain score reaches baseline or more. Follow-up will be terminated as this reflected a loss of pain relief. Patients will be followed by on day 7,30,60 and 90.Timepoint: day 7, 30.60 and 90. | — |
Countries
India
Contacts
Public ContactManish Panwar
AIIMS Rishikesh
Outcome results
None listed