Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJanuary 21, 2026
December 1, 2019
4.3 years
June 16, 2016
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
detection of undiagnosed postoperative complication by CT scan
Day 7
Study Arms (1)
pancreatic surgery
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu Reims
Reims, 51092, France
Related Publications (1)
Durot C, Rousset P, Thivolet A, Passot G, Deguelte S, Dohan A, Glehen O, Hoeffel C. What the radiologist should know about postoperative MDCT evaluation of a patient treated with cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy. Clin Radiol. 2018 Jun;73(6):517-525. doi: 10.1016/j.crad.2018.02.001. Epub 2018 Mar 21.
PMID: 29573786BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 28, 2016
Study Start
January 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
January 21, 2026
Record last verified: 2019-12