NCT00855985

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

7.3 years

First QC Date

March 4, 2009

Last Update Submit

September 24, 2011

Conditions

Pancreatic CancerPancreatic Fistula

Keywords

Pancreatic anastomosisWhipple operation

Outcome Measures

Primary Outcomes (1)

  • pancreatic fistula rate

    30 days

Secondary Outcomes (4)

  • mortality

    90 days

  • Hospital stay

    90 days

  • need for postoperative intervention

    90 days

  • major complication

    90 days

Study Arms (2)

1

ACTIVE COMPARATOR

Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy

Procedure: type of anastomosis after pancreaticoduodenectomy

2

ACTIVE COMPARATOR

Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy

Procedure: type of anastomosis after pancreaticoduodenectomy

Interventions

type of anastomosis after pancreaticoduodenectomyPROCEDURE

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

12

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
  • resectable tumour

You may not qualify if:

  • chronic pancreatitis/benign tumours-
  • tumours extending into the body of the pancreas
  • tumours with metastasis beyond regional lymph nodes
  • requirement for sub total pancreatectomy
  • prolonged hypotension - \< 80 mm of hg for more than 30 min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakeshore Hospital & Research Center

Kochi, Kerala, 682024, India

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hariharan Ramesh, MS MCh

    Lakeshore Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Surgical Gastroenterology

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

July 1, 2004

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

IN(1)