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Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

Primary Purpose

Pancreatectomy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT scan
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Will be included in this study, patients:

  • Having an indication of pancreatic surgery
  • In scheduled surgery
  • Agreeing to participate in the research (ie who signed the informed consent to research participation)
  • >18yo

Exclusion Criteria:

Will not be included in this study, patients:

  • With emergency surgery
  • Protected by law
  • Under 18 years
  • Presenting an against-indications to the scanner: documented severe allergy to contrast material, kidney failure against-showing the contrast medium injection, pregnancy, lactation and/or MRI (pacemaker, metallic intraocular foreign body)

Sites / Locations

  • Chu Reims

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pancreatic surgery

Arm Description

Outcomes

Primary Outcome Measures

detection of undiagnosed postoperative complication by CT scan

Secondary Outcome Measures

Full Information

First Posted
June 16, 2016
Last Updated
December 13, 2019
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT02814812
Brief Title
Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery
Official Title
Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

5. Study Description

Brief Summary
Pancreatectomy represents the classic approach for resectable lesions of the pancreas, duodenum and periampullary region. Due to the technical skills required, the complex anatomy and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still considered to be at risk of postoperative complication mainly due to pancreatic juice leaks. Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the activation of pancreatic enzymes and the following infectious and hemorrhagic complications. Severe complications negatively affect postoperative outcomes, long-term survival, quality of life, and costs. Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization. But in pancreatic surgery mortality rates within 90 days after pancreatic resection are double those at 30 days. In the present study, the investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh postoperative day before discharging the patients to detect undiagnosed postoperative complication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pancreatic surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
CT scan
Primary Outcome Measure Information:
Title
detection of undiagnosed postoperative complication by CT scan
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Will be included in this study, patients: Having an indication of pancreatic surgery In scheduled surgery Agreeing to participate in the research (ie who signed the informed consent to research participation) >18yo Exclusion Criteria: Will not be included in this study, patients: With emergency surgery Protected by law Under 18 years Presenting an against-indications to the scanner: documented severe allergy to contrast material, kidney failure against-showing the contrast medium injection, pregnancy, lactation and/or MRI (pacemaker, metallic intraocular foreign body)
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

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Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

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