Endoscopic Versus Surgical Treatment of Chronic Pancreatitis

NCT01520675 | Unknown DMC

• 1 other identifier: IESC/T-187/2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic pancreatitis; randomized controlled trial; endoscopic therapy; surgery; ESWL

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Relief in pain

  1 year

Secondary Outcomes (4)

• Quality of life

  6 Month

• Morbidity

  30 days

• Mortality

  30 day

• Changes in pancreatic endocrine function

  6 Month

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Patients will be randomized to surgery

Procedure: surgery

Endotherapy

ACTIVE COMPARATOR

Patients will be randomized to endoscopic therapy

Procedure: Endoscopic therapy

Interventions

surgery PROCEDURE

Drainage procedure

Also known as: lateral pancreaticojejunostomy

Surgery

Endoscopic therapy PROCEDURE

pancreatic sphincterotomy, removal of calculi, stenting, ESWL

Also known as: Pancreatic endotherapy

Endotherapy

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic pancreatitis
• Failed medical treatment
• Dilated pancreatic duct ( \> 5mm)

You may not qualify if:

• Age under 12 or more than 70 years
• Pregnancy
• Multiple (\> 3) large stone (\> 1.5 cm) in head of pancreas or stones present throughout head, body and tail
• Contraindications to surgery
• American Society of Anesthesiologists class IV
• Portal hypertension
• Contraindications to endoscopic treatment
• Gastrectomy with Billroth II reconstruction
• Other pancreatitis-related complications requiring surgery
• Previous interventional therapy for chronic pancreatitis
• Pancreatic endotherapy
• Previous surgery
• Suspected pancreatic cancer
• Refusal to participate

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

AIIMS

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikhil Agrawal, MS

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• T K Chattopadhyay

  All India Institute of Medical Sciences

  STUDY DIRECTOR

• Peush Sahni

  All India Institute of Medical Sciences

  STUDY DIRECTOR

• Sujoy Pal

  All India Institute of Medical Sciences

  STUDY CHAIR

• N R Dash

  All India Institute of Medical Sciences

  STUDY CHAIR

• Pramod Garg

  All India Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 30, 2012
• Study Start: July 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

IN (1)