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Anastomotic Techniques in Pancreaticoduodenectomy

NCT ID: NCT00855985

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Pancreatic Cancer Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy

Group Type ACTIVE_COMPARATOR

type of anastomosis after pancreaticoduodenectomy

Intervention Type PROCEDURE

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

2

Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy

Group Type ACTIVE_COMPARATOR

type of anastomosis after pancreaticoduodenectomy

Intervention Type PROCEDURE

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

Interventions

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type of anastomosis after pancreaticoduodenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lakeshore Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr H Ramesh

Director of Surgical Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hariharan Ramesh, MS MCh

Role: PRINCIPAL_INVESTIGATOR

Lakeshore Hospital

Locations

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Lakeshore Hospital & Research Center

Kochi, Kerala, India

Site Status

Countries

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India

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id