Anastomotic Techniques in Pancreaticoduodenectomy (PG/PJ)

Lakeshore Hospital

Status: Unknown

Conditions: Pancreatic Fistula; Pancreatic Cancer

Treatments: Procedure: type of anastomosis after pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00855985

001

Details and patient eligibility

About

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

Enrollment: 312 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

1

Active Comparator group

Description:

Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy

Treatment:

Procedure: type of anastomosis after pancreaticoduodenectomy

2

Active Comparator group

Description:

Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy

Treatment:

Procedure: type of anastomosis after pancreaticoduodenectomy