Endoscopic Versus Surgical Treatment of Chronic Pancreatitis

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Brief Title

Endoscopic Versus Surgical Treatment of Chronic Pancreatitis

Official Title

Endoscopic Versus Surgical Treatment of Chronic Pancreatitis - A Randomized Controlled Trial

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.
    


Study Type

Interventional


Primary Outcome

Pain relief

Secondary Outcome

 Quality of life

Condition

Chronic Pancreatitis

Intervention

surgery

Study Arms / Comparison Groups

 Surgery
Description:  Patients will be randomized to surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

50

Start Date

July 2010

Completion Date

December 2017

Primary Completion Date

December 2017

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
      

Gender

All

Ages

12 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Nikhil Agrawal, MS, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01520675

Organization ID

IESC/T-187/2010


Responsible Party

Principal Investigator

Study Sponsor

All India Institute of Medical Sciences, New Delhi


Study Sponsor

Nikhil Agrawal, MS, Principal Investigator, All India Institute of Medical Sciences, New Delhi


Verification Date

June 2017