Endoscopic Versus Surgical Treatment of Chronic Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Pramod Kumar Garg, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01520675
First received: January 19, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Chronic Pancreatitis
Procedure: surgery
Procedure: Endoscopic therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Versus Surgical Treatment of Chronic Pancreatitis - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Changes in pancreatic endocrine function [ Time Frame: 6 Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery
Patients will be randomized to surgery
Procedure: surgery
Drainage procedure
Other Name: lateral pancreaticojejunostomy
Active Comparator: Endotherapy
Patients will be randomized to endoscopic therapy
Procedure: Endoscopic therapy
pancreatic sphincterotomy, removal of calculi, stenting, ESWL
Other Name: Pancreatic endotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520675

Contacts
Contact: Pramod Garg, MS +919868397205 pgarg10@gmail.com

Locations
India
AIIMS Recruiting
New Delhi, Delhi, India, 110029
Contact: Pramod Garg    +919868397205    pgarg10@gmail.com   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Nikhil Agrawal, MS All India Institute of Medical Sciences, New Delhi
Study Director: T K Chattopadhyay All India Institute of Medical Sciences, New Delhi
Study Director: Peush Sahni All India Institute of Medical Sciences, New Delhi
Study Chair: Sujoy Pal All India Institute of Medical Sciences, New Delhi
Study Chair: N R Dash All India Institute of Medical Sciences, New Delhi
Study Director: Pramod Garg All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Pramod Kumar Garg, Additional Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01520675     History of Changes
Other Study ID Numbers: IESC/T-187/2010
Study First Received: January 19, 2012
Last Updated: July 10, 2013
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
chronic pancreatitis
randomized controlled trial
endoscopic therapy
surgery
ESWL

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 25, 2014