Overview

This trial is active, not recruiting.

Conditions pancreatic cancer, pancreatic fistula
Treatment type of anastomosis after pancreaticoduodenectomy
Sponsor Lakeshore Hospital
Start date July 2004
End date October 2011
Trial size 312 participants
Trial identifier NCT00855985, 001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy
type of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
(Active Comparator)
Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy
type of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy

Primary Outcomes

Measure
pancreatic fistula rate
time frame: 30 days

Secondary Outcomes

Measure
mortality
time frame: 90 days
Hospital stay
time frame: 90 days
need for postoperative intervention
time frame: 90 days
major complication
time frame: 90 days

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
Principal investigator Hariharan Ramesh, MS MCh
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Lakeshore Hospital.