Anastomotic Techniques in Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

— PG/PJ  

Official title:

A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00855985
• Other study ID #: 001
• Status: Active, not recruiting
• Phase: N/A
• First received: March 4, 2009
• Last updated: September 24, 2011
• Start date: July 2004
• Est. completion date: October 2011

Study information

• Verified date: September 2011
• Source: Lakeshore Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: ethics committee of Lakeshore Hospital
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

Procedure:
• type of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy

Locations

Country	Name	City	State
India	Lakeshore Hospital & Research Center	Cochin	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Lakeshore Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic fistula rate		30 days	Yes
Secondary	mortality		90 days	Yes
Secondary	Hospital stay		90 days	No
Secondary	need for postoperative intervention		90 days	Yes
Secondary	major complication		90 days	Yes