Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy

NCT01913275 | Withdrawn DMC

• 1 other identifier: GIS/2/2001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Periampullary Cancer; Pancreatic Cancer

Keywords

cholecystojejunostomy; whipple's pancreaticoduodenectomy; endoscopic stenting; hyperbilirubinemia

Outcome Measures

Primary Outcomes (4)

• Technical success

  Passage of a stent across the stricture, along with flow of bile through the stent

  2 minutes

• Successful drainage

  A decrease in bilirubin of at least 20% of the pretreatment value within 5 days after procedure

  5 days

• Procedure-related complication: was defined complications directly related to stent insertion/CJ

  30 days

• Intraoperative assessment

  The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery.

  0 hour

Secondary Outcomes (8)

• 1. Procedure-related mortality

  30 days

• 2. Duration of hospital stay

  30 days

• 3. Postoperative complication:

  30 days

• a. Wound infection

  30 days

• b. Intra-abdominal abscess

  30 days

Study Arms (2)

endoscopic stenting

ACTIVE COMPARATOR

endoscopic stenting to reduce preoperative jaundice

Procedure: Endoscopic stenting

cholecystojejunostomy

ACTIVE COMPARATOR

surgical procedure to decrease preoperative jaundice

Procedure: cholecystojejunostomy

Interventions

Endoscopic stenting PROCEDURE

Endoscopic stenting to decrease preopertaive jaundice

endoscopic stenting

cholecystojejunostomy PROCEDURE

surgical procedure to decrease preoperative jaundice

cholecystojejunostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with gastric outlet obstruction.
• Patients with unresectable tumour assessed by imaging techniques.
• Patients with a history of cholecystectomy and Billroth II gastrectomy.
• Patients stented outside

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical sciences

New Delhi, 110008, India

Location

Related Publications (1)

• Povoski SP, Karpeh MS Jr, Conlon KC, Blumgart LH, Brennan MF. Association of preoperative biliary drainage with postoperative outcome following pancreaticoduodenectomy. Ann Surg. 1999 Aug;230(2):131-42. doi: 10.1097/00000658-199908000-00001.

  PMID: 10450725 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tushar K Chattopadhyay, MS

  Department of GI surgery All India Institute of medical sciences, New Delhi, India

  STUDY DIRECTOR

• Sundeep S Saluja, MCh

  Department of GI surgery , All India Institute Of medical sciences, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: August 1, 2013
• Study Start: March 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

IN (1)