Anastomotic Techniques in Pancreaticoduodenectomy

Not Applicable

• Conditions: Pancreatic Cancer; Pancreatic Fistula

• Registration Number: NCT00855985
• Lead Sponsor: Lakeshore Hospital

Brief Summary

There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.

Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-05
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-24
• Last Update Posted: 2011-09-27
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
2. resectable tumour

Exclusion Criteria

1. chronic pancreatitis/benign tumours-
2. tumours extending into the body of the pancreas
3. tumours with metastasis beyond regional lymph nodes
4. requirement for sub total pancreatectomy
5. prolonged hypotension - < 80 mm of hg for more than 30 min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pancreatic fistula rate	30 days

Secondary Outcome Measures

Name	Time	Method
mortality	90 days
Hospital stay	90 days
need for postoperative intervention	90 days
major complication	90 days

Trial Locations

Locations (1)

Lakeshore Hospital & Research Center; 🇮🇳 Cochin, Kerala, India