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Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Collaborator:
KK Nuclear Scan
Information provided by:
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01191138
First received: August 26, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric emptying.

The study compares two types of anastamosis of stomach to jejunum (supracolic and infracolic) and compares whether it influences the gastric emptying.

The clinical evidence of delayed gastric emptying is correlated with objective evidence of liquid and solid emptying by radionuclide study.

The study also tries to evaluate whether pancreatic leak correlates with delayed gastric emptying


Condition Intervention
Postprocedural Gastric Stasis
 Procedure: Infracolic gastrojejunal anastamosis
Procedure: Supracolic gastrojejunal anastamosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Control Trial Comparing Gastric Emptying Following Infracolic vs Supracolic Gastrojejunostomy After Whipples Pancreaticoduodenectomy

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Gastric emptying in the postoperative period in the form of tolerence of food and removal of ryles tube is assessed. This is correlated with liquid and solid emptying of radionucleotide


Secondary Outcome Measures:
  • Correlation of pancreatic duct leak with gastric emptying [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    The pancreatic duct leak is correlated with gastric emptying


Estimated Enrollment: 60
Study Start Date: January 2009
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Infracolic Anastamosis
The gastrojejunal anastamosis is done in the infracolic compartment
 Procedure: Infracolic gastrojejunal anastamosis
Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the infracolic compartment by bringing down the stomach below the mesocolon to the left of the middle colic artery
Other Name: Infracolic and retrocolic Gastrojejunostomy
Supracolic Anastamosis
The gastrojejunal anastamosis is done in the supracolic compartment
 Procedure: Supracolic gastrojejunal anastamosis
Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the supracolic compartment.
Other Name: Supracolic and retrocolic gastrojejunostomy

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Whipples procedure

Exclusion Criteria:

  • Unresectable tumors at surgery
  • Postoperative mechanical obstruction
  • Postoperative mortality, where the test could not be done
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191138

Locations
India
Asian Institute Of Gastroenterology India
Hyderabad, Andhra Pradesh, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
KK Nuclear Scan
Investigators
Principal Investigator: Pradeep Rebala, MS., M Ch Asian Institute of Gastroenterology
  More Information

No publications provided

Responsible Party: Pradeep Rebala, Asian Institute of Gastroenterology
ClinicalTrials.gov Identifier: NCT01191138     History of Changes
Other Study ID Numbers: AIG-GIS-20090
Study First Received: August 26, 2010
Last Updated: June 19, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Asian Institute of Gastroenterology, India:
Delayed Gastric emptying
Gastric emptying scintigraphy
Pancreatic fistula
Pancreatic Neoplasms
Whipple Operation

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013