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

Pancreatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814812
• Other study ID #: PO14086
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: May 1, 2018

Study information

• Verified date: December 2019
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatectomy
• Postoperative Complications

Intervention

Procedure:
• CT scan

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of undiagnosed postoperative complication by CT scan		Day 7