Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy
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|ClinicalTrials.gov Identifier: NCT01913275|
Recruitment Status : Unknown
Verified July 2013 by Peush Sahni, All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Recruiting
First Posted : August 1, 2013
Last Update Posted : August 1, 2013
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 or disease||Intervention/treatment||Phase|
|Periampullary Cancer Pancreatic Cancer||Procedure: Endoscopic stenting Procedure: cholecystojejunostomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||February 2014|
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
surgical procedure to decrease preoperative jaundice
- Technical success [ Time Frame: 2 minutes ]Passage of a stent across the stricture, along with flow of bile through the stent
- Successful drainage [ Time Frame: 5 days ]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 ]
- Intraoperative assessment [ Time Frame: 0 hour ]The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery.
- 1. Procedure-related mortality [ Time Frame: 30 days ]was defined as death directly related to complications of stent insertion/CJ
- 2. Duration of hospital stay [ Time Frame: 30 days ]Number of days in hospital from the time of surgery or stenting to initial discharge.
- 3. Postoperative complication: [ Time Frame: 30 days ]Complications occurring within 30 days after pancreaticoduodenectomy
- a. Wound infection [ Time Frame: 30 days ]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 ]when pus was drained, aspirated or discharged from the peritoneal cavity
- c. Postoperative haemorrhage [ Time Frame: 30 days ]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 ]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 ]Clinical bile leak or elevated bilirubin level in drain fluid with normal serum level.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913275
|Contact: Tushar K Chattopadhyay, MS||911126588700 ext firstname.lastname@example.org|
|Contact: Peush Sahni, MS PHD||911126588700 ext email@example.com|
|All India Institute of Medical sciences||Recruiting|
|New Delhi, India, 110008|
|Principal Investigator: Sundeep S Saluja, Mch|
|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|