Trial record 9 of 27 for:    Whipple's Disease

Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy

This study is currently recruiting participants.
Verified July 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Peush Sahni, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01913275
First received: May 10, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

Periampullary carcinoma and carcinoma head of pancreas are common causes of obstruction at the lower end of the common bile duct. Whenever possible, surgical resection in the form of Whipple Pancreaticoduodenectomy (WPD) is the treatment of choice. However, this operation is associated with a substantial postoperative morbidity and mortality. With advances in surgical techniques and postoperative care there has been a decrease in the operative mortality. However, the postoperative morbidity remains high varying between 5%-64%. Of the various risk factors, the degree of jaundice as indicated by the serum bilirubin levels has been associated with an increased risk of complications. Preoperative biliary drainage has been tried to decrease the serum bilirubin levels and consequently decrease postoperative morbidity and mortality. Internal biliary drainage can be achieved by surgical cholecystojejunostomy or endoscopic bile duct stenting. Endoscopic stenting can be done as a day care procedure under conscious sedation, but involves insertion of a foreign body (stent), which results in introduction of bacteria into the bile and problems of postoperative infection. Also, endoscopic stenting before surgery may result in difficulty in dissecting around the common bile duct during the surgical procedure. While the surgical bilioenteric bypass has the advantage that no foreign body is inserted into the biliary tree and hence the likelihood of sepsis is low, it requires anesthesia and involves a surgical incision.

There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in patients undergoing pancraticoduodenectomy. We plan to compare the outcomes of preoperative endoscopic biliary drainage with surgical drainage in patients undergoing pancreaticoduodenectomy.


Condition Intervention
Periampullary Cancer
Pancreatic Cancer
Procedure: Endoscopic stenting
Procedure: cholecystojejunostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Technical success [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    Passage of a stent across the stricture, along with flow of bile through the stent

  • Successful drainage [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    A decrease in bilirubin of at least 20% of the pretreatment value within 5 days after procedure

  • Procedure-related complication: was defined complications directly related to stent insertion/CJ [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Intraoperative assessment [ Time Frame: 0 hour ] [ Designated as safety issue: No ]
    The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery.


Secondary Outcome Measures:
  • 1. Procedure-related mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    was defined as death directly related to complications of stent insertion/CJ

  • 2. Duration of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of days in hospital from the time of surgery or stenting to initial discharge.

  • 3. Postoperative complication: [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Complications occurring within 30 days after pancreaticoduodenectomy

  • a. Wound infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    presence of purulent discharge with or without growth of microorganism or serous discharge that grows a pathogenic microorganism.

  • b. Intra-abdominal abscess [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    when pus was drained, aspirated or discharged from the peritoneal cavity

  • c. Postoperative haemorrhage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Hematemesis, malena, blood los from the abdominal wound or drian site requiring 2 or more units of blood transfusion.

  • d. Pancreaticojejunal leak [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Drain fluid amaylase level > 3 times the serum amylase on postoperative day 3 or beyond or percutaneous drainage of amylase rich intra-abdominal collection, with or without clinical sequelae such as fever, leucocytosis, fistula

  • e. Bile leak [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Clinical bile leak or elevated bilirubin level in drain fluid with normal serum level.


Estimated Enrollment: 134
Study Start Date: March 2006
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: endoscopic stenting
endoscopic stenting to reduce preoperative jaundice
Procedure: Endoscopic stenting
Endoscopic stenting to decrease preopertaive jaundice
Active Comparator: cholecystojejunostomy
surgical procedure to decrease preoperative jaundice
Procedure: cholecystojejunostomy
surgical procedure to decrease preoperative jaundice

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with periampullary carcinoma and carcinoma of the head of pancreas.
  2. Patients with serum bilirubin >15mg/dl

Exclusion Criteria:

  1. Patients with gastric outlet obstruction.
  2. Patients with unresectable tumour assessed by imaging techniques.
  3. Patients with a history of cholecystectomy and Billroth II gastrectomy.
  4. Patients stented outside
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01913275

Contacts
Contact: Tushar K Chattopadhyay, MS 911126588700 ext 3461 tkc46@hotmail.com
Contact: Peush Sahni, MS PHD 911126588700 ext 4879 peush_sahni@hotmail.com

Locations
India
All India Institute of Medical sciences Recruiting
New Delhi, India, 110008
Principal Investigator: Sundeep S Saluja, Mch         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: Tushar K Chattopadhyay, MS Department of GI surgery All India Institute of medical sciences, New Delhi, India
Principal Investigator: Sundeep S Saluja, MCh Department of GI surgery , All India Institute Of medical sciences, New Delhi, India
  More Information

Publications:
Responsible Party: Peush Sahni, Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01913275     History of Changes
Other Study ID Numbers: GIS/2/2001
Study First Received: May 10, 2011
Last Updated: July 30, 2013
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
cholecystojejunostomy
whipple's pancreaticoduodenectomy
endoscopic stenting
hyperbilirubinemia

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014