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

Not Applicable

Completed

• Conditions: Pancreatectomy
• Interventions: Procedure: CT scan

• Registration Number: NCT02814812
• Lead Sponsor: CHU de Reims

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pancreatic surgery	CT scan	-

Primary Outcome Measures

Name	Time	Method
detection of undiagnosed postoperative complication by CT scan	Day 7

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France