Endoscopic Versus Surgical Treatment of Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
surgery
Endoscopic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis focused on measuring chronic pancreatitis, randomized controlled trial, endoscopic therapy, surgery, ESWL
Eligibility 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
Sites / Locations
- AIIMS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgery
Endotherapy
Arm Description
Patients will be randomized to surgery
Patients will be randomized to endoscopic therapy
Outcomes
Primary Outcome Measures
Pain relief
Relief in pain
Secondary Outcome Measures
Quality of life
QoL score
Morbidity
Any comoplications
Mortality
Mortality
Changes in pancreatic endocrine function
Development or change in diabetes
Full Information
NCT ID
NCT01520675
First Posted
January 19, 2012
Last Updated
June 27, 2017
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT01520675
Brief Title
Endoscopic Versus Surgical Treatment of Chronic Pancreatitis
Official Title
Endoscopic Versus Surgical Treatment of Chronic Pancreatitis - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Chronic pancreatitis is a progressive inflammatory disease of the pancreas characterized by destruction of pancreatic parenchyma and subsequent fibrosis. The prevalence of chronic pancreatitis has been found to be very high in southern India (114-200/100 000 population). Alcohol is the most common etiology worldwide, while idiopathic pancreatitis is the most common type in India and China, accounting for approximately 70% of all cases of chronic pancreatitis. It is a cause of considerable morbidity in the form of pain, steatorrhea and diabetes mellitus. Natural history of chronic pancreatitis is characterized by variable course stretching over decades with recurrent acute pancreatitis in the early stage and steatorrhea, diabetes and pancreatic calcification in the later stages. Pain is a prominent clinical feature of chronic pancreatitis and the most troublesome symptom for which medical attention is often sought. Unfortunately, despite much work, the pathophysiology of pain in CP remains poorly understood. Multiple factors have been suspected, which include inflammation, encasement of sensory nerves by the fibrotic process and neuropathy, and duct obstruction, which can lead to high back pressure and parenchymal ischemia. Increased pressure in the main pancreatic duct is likely to be an important cause of pain, particularly in patients with duct dilatation. This explanation forms the conceptual basis for both endoscopic and surgical drainage procedures. Approximately one half of patients with pain owing to chronic pancreatitis come to an intervention aimed principally at pain relief, along with relief of bile duct, duodenal, and major venous obstruction. Patients with chronic pancreatitis can be treated with medical management, endoscopic therapy and surgical treatment. For patients with dilated ducts, ductal decompression is advocated. The pros and cons of endoscopic versus surgical therapy are debated.
The modified Puestow or lateral pancreaticojejunostomy is the most commonly employed surgical procedure. 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.
Overall 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.
Dite et al. reported the first trial. Surgery consisted of resection (80 %) and drainage (20 %) procedures, while endotherapy included sphincterotomy and stenting (52 %) and/or stone removal (23 %). In the entire group, the initial success rates were similar for both groups, but at the 5-year follow-up, complete absence of pain was more frequent after surgery (37 % vs. 14 %), with the rate of partial relief being similar (49 % vs. 51 %). In the randomized subgroup, results were similar (pain absence 34 % after surgery vs. 15 % after endotherapy, relief 52 % after surgery vs. 46 % after endotherapy). The increase in body weight was also greater by 20 - 25 % in the surgical group, while new-onset diabetes developed with similar frequency in both groups (34 - 43 %), again with no differences between the results for the whole group and the randomized subgroup. The authors concluded that surgery is superior to endotherapy for long-term pain reduction in patients with painful obstructive chronic pancreatitis.
Cahen et al. reported the second trial. All symptomatic patients with chronic pancreatitis and a distal obstruction of the pancreatic duct but without an inflammatory mass were eligible for the study. Thirty-nine patients underwent randomization: 19 to endoscopic treatment (16 of whom underwent lithotripsy) and 20 to operative pancreaticojejunostomy. During the 24 months of follow-up, patients who underwent surgery, as compared with those who were treated endoscopically, had lower Izbicki pain scores (25 vs. 51, P<0.001) and better physical health summary scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey questionnaire (P=0.003). At the end of follow-up, complete or partial pain relief was achieved in 32% of patients assigned to endoscopic drainage as compared with 75% of patients assigned to surgical drainage (P=0.007). Rates of complications, length of hospital stay, and changes in pancreatic function were similar in the two treatment groups, but patients receiving endoscopic treatment required more procedures than did patients in the surgery group (a median of eight vs. three, P<0.001). Authors concluded that surgical drainage of the pancreatic duct was more effective than endoscopic treatment in patients with obstruction of the pancreatic duct due to chronic pancreatitis.
Both these trials had a small sample size. The population studied was also different. ESWL was not included in protocol in one of the trials. In one of the trials only pancreatic duct drainage was chosen as the surgical therapy. The proposed study will compare surgery with endoscopic therapy in Indian population with chronic pancreatitis. The outcomes compared would include pain relief, quality of life, morbidity, mortality, length of hospital stay and changes in pancreatic endocrine and exocrine function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
chronic pancreatitis, randomized controlled trial, endoscopic therapy, surgery, ESWL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Patients will be randomized to surgery
Arm Title
Endotherapy
Arm Type
Active Comparator
Arm Description
Patients will be randomized to endoscopic therapy
Intervention Type
Procedure
Intervention Name(s)
surgery
Other Intervention Name(s)
lateral pancreaticojejunostomy
Intervention Description
Drainage procedure
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy
Other Intervention Name(s)
Pancreatic endotherapy
Intervention Description
pancreatic sphincterotomy, removal of calculi, stenting, ESWL
Primary Outcome Measure Information:
Title
Pain relief
Description
Relief in pain
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life
Description
QoL score
Time Frame
6 Month
Title
Morbidity
Description
Any comoplications
Time Frame
30 days
Title
Mortality
Description
Mortality
Time Frame
30 day
Title
Changes in pancreatic endocrine function
Description
Development or change in diabetes
Time Frame
6 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Agrawal, MS
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
T K Chattopadhyay
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peush Sahni
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sujoy Pal
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
N R Dash
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pramod Garg
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Director
Facility Information:
Facility Name
AIIMS
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
12. IPD Sharing Statement
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Endoscopic Versus Surgical Treatment of Chronic Pancreatitis
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