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Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy

NCT01913275 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Endoscopic stenting

Endoscopic stenting to decrease preopertaive jaundice

PROCEDURE

cholecystojejunostomy

surgical procedure to decrease preoperative jaundice

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Tushar K Chattopadhyay, MS · Department of GI surgery All India Institute of medical sciences, New Delhi, India

  • Sundeep S Saluja, MCh · Department of GI surgery , All India Institute Of medical sciences, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913275 on ClinicalTrials.gov