Anastomotic Techniques in Pancreaticoduodenectomy

Lakeshore Hospital312 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

312

Conditions

Pancreatic Cancer Pancreatic Fistula

Interventions

type of anastomosis after pancreaticoduodenectomyPROCEDURE

pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Lakeshore Hospital & Research Center

Kochi, Kerala, India

Outcomes

Primary Outcomes

pancreatic fistula rate

Time frame: 30 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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