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A trial to compare pain in patients with chronic pancreatitis undergoing early versus late surgery.

The Early Surgery versus surgery as last resort for Chronic Pancreatitis-(ESSLaR) trial. - ESSLaR Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052196
Enrollment
60
Registered
2023-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K860- Alcohol-induced chronic pancreatitis

Interventions

Intervention1: SURGICAL MANGEMENT in EARLY CHRONIC PANCREAITIS WITH NON-DEBILITATING PAIN: Patients in this group are diagnosed cases of chronic pancreatitis as per inclusion criteria with early non d

Sponsors

Department of surgical gastroenterology.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria Age > 18 years typical clinical history of chronic pancreatitis ? one or more of the following additional criteria for the diagnosis of CP: 1. Pancreatic calcifications on CT or MRI imaging. 2. Moderate or marked ductal lesions on endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance cholangiopancreatography (MRCP) imaging. 3. Marked and persistent exocrine insufficiency (defined as: a. pancreatic steatorrhea clearly relieved by enzyme supplementation, and/or b. fecal elastase levels of = 200 micro gram/gram) 4. Dilated pancreatic duct: dilated pancreatic duct of = 5 mm, with or without enlargement of the pancreatic head. 5. Presence of moderate, non-debilitating pain FOR EARLY SURGERY GROUP 6 Presence of debilitating pain not amenable to strong opiods for standard surgery group

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. History of prolonged need of opioids- weak opioids for CP for a total period of 6 months in the last 2 years. 2. Previous pancreatic surgery 3. Previous endoscopic dilatation or stenting of the pancreatic duct /biliary 4. Autoimmune pancreatitis 5. Stones and strictures exclusively located in the tail of the pancreas 6. Fully impacted stones casting the entire main pancreatic duct (from head to tail) and possibly side branches 7. Suspected or confirmed pancreatic malignancy 8. Life expectancy of 9. Presence of duodenal obstruction necessitating surgery. 10. Presence of a pseudocyst larger than 6 cm necessitating intervention. 11. severe portal hypertension due to occluded portal vein 12. Pregnancy

Design outcomes

Primary

MeasureTime frame
To comparison of pain score after early surgery in CP with current Standard management (late surgery).Timepoint: 12 months

Secondary

MeasureTime frame
To assesses the quality of life, post procedural complications, disease progression, exocrine and endocrine dysfunction during the follow up period.Timepoint: 2 years

Countries

India

Contacts

Public Contactvivek g nath

Department of surgical Gastroenterology, Thanjavur medical college

aravigastro@yahoo.co.in9842435515

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026