Clinical Trial: Laparoscopic Cystogastrostomy Versus Endoscopic Cystogastrostomy

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Endoscopic Drainage for Pseudocyst of the Pancreas

Brief Summary: This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary outcomes will be complications, recurrence and cost analysis between the two methods.

Detailed Summary:

This study will be conducted in the Department of Surgical Disciplines and Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi. Patients with pancreatic pseudocyst will be randomized to two groups-

Group I- Laparoscopic management of the pseudocyst Group II- Endoscopic management of the pseudocyst

Patients will be randomized using computer generated randomized numbers in sealed envelopes to ensure concealed allocation with block randomization. The details of patients who do not meet inclusion criteria and those who refuse consent and reason for refusal of consent will also be noted. Refusal for consent for inclusion in the study will not hamper the treatment of these patients in anyway. The patients will be evaluated prospectively. CONSORT guidelines will be followed.

Preoperative Data

The details regarding demographic profile of the patient i.e. age/ sex/ body mass index (BMI) and clinical features will be noted. The duration and presenting complaint for pseudocyst and history regarding the acuteness of underlying pancreatic disease will be noted. The etiology of pancreatitis will be noted. Patients will be examined thoroughly and the characteristic features of the pseudocysts, the size and the site (head, body or tail of the pancreas) will be noted. The American Society of Anesthesiologists (ASA) grading of the patient will also be done.

Pre-operative Investigations

Preoperative investigations will include hemogram, liver function tests, serum electrolytes, serum amylase, serum lipase, kidney function tests, chest X-ray and electrocardiogram. Ultrasound of the abdomen, and contrast enhanced com
Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome: Resolution of Pseudocyst [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse Events [ Time Frame: 4 weeks ]
    Bleeding, sepsis, chest complications and other important events in the post procedure period requiring prolonged stay and /or repeat procedure
  • Cost per patient [ Time Frame: 4 weeks ]
    Cost effectiveness to be calculated from the average cost per patient and the number of successful outcomes.
  • Recurrence rate of pseudocyst [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: July 10, 2013
Date Started: August 2011
Date Completion: March 2015
Last Updated: January 18, 2014
Last Verified: January 2014