MedPath

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

Not Applicable
Conditions
Health Condition 1: K860- Alcohol-induced chronic pancreatitis
Registration Number
CTRI/2023/05/052196
Lead Sponsor
Department of surgical gastroenterology.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Inclusion criteria

Age > 18 years

typical clinical history of chronic pancreatitis

â?ª 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

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 < 1 year for any reason

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To comparison of pain score after early surgery in CP with current Standard management (late surgery).Timepoint: 12 months
Secondary Outcome Measures
NameTimeMethod
To assesses the quality of life, post procedural complications, disease progression, exocrine and endocrine dysfunction during the follow up period.Timepoint: 2 years
© Copyright 2025. All Rights Reserved by MedPath