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

NCT ID: NCT02814812

Last Updated: 2019-12-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pancreatic surgery

Group Type EXPERIMENTAL

CT scan

Intervention Type PROCEDURE

Interventions

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CT scan

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PO14086

Identifier Type: -

Identifier Source: org_study_id