Endoscopic Versus Surgical Treatment of Chronic Pancreatitis

Summary

Chronic pancreatitis is a progressive inflammatory disease of the pancreas characterized by destruction of pancreatic parenchyma and subsequent fibrosis. Patients with chronic pancreatitis can be treated with medical management, endoscopic therapy and surgical treatment. Among the various theories of causation of pain in chronic pancreatitis, there is theory of ductal hypertension. In this the pancreatic duct obstruction resulting in ductal dilatation, ductal hypertension and parenchymal hypertension is thought to be the cause of pain. For patients with dilated ducts, ductal decompression is advocated. Ductal decompression can be achieved by endoscopy and by surgery. Surgery comprises of lateral pancreaticojejunostomy with or without headcoring. Endoscopic treatment includes sphincterotomy, dilatation of strictures, removal of stones with or without extracorporeal shock wave lithotripsy (ESWL) and stenting. The pros and cons of endoscopic versus surgical therapy are debated. Lateral pancreaticojejunostomy relieves chronic abdominal pain in 65%-93% of patients. Morbidity and mortality rates are generally low, averaging 20% and 2%, respectively. Long-term follow-up of patients after lateral pancreaticojejunostomy reveals that up to 50% of patients develop recurrent symptoms and 10%-35% fail to obtain pain relief. Studies indicate that more than 60% of patients undergoing pancreatic endotherapy are pain free 1 year after the procedure. There are only two randomized controlled trials comparing endoscopic treatment with the surgical therapy. In this study the investigators will be conducting a randomized trial, to compare endoscopic and surgical treatment of chronic pancreatitis. Outcome variables measured in the study will include pain relief, quality of life, morbidity, mortality, length of hospital stay and changes in pancreatic function.

Conditions

• Chronic Pancreatitis

Interventions

PROCEDURE

surgery

Drainage procedure

PROCEDURE

Endoscopic therapy

pancreatic sphincterotomy, removal of calculi, stenting, ESWL

Sponsors & Collaborators

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Nikhil Agrawal, MS · All India Institute of Medical Sciences

• T K Chattopadhyay · All India Institute of Medical Sciences

• Peush Sahni · All India Institute of Medical Sciences

• Sujoy Pal · All India Institute of Medical Sciences

• N R Dash · All India Institute of Medical Sciences

• Pramod Garg · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• India

Study Locations