Bleeding Clinical Trial
— PFOfficial title:
Study of Pancreatic Fistula and Bleeding Complication After Pancreaticoduodenectomy in Treatment Periampullary Cancer
NCT number | NCT04985071 |
Other study ID # | VTrQuoc |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | October 31, 2023 |
Verified date | May 2024 |
Source | University of Medicine and Pharmacy at Ho Chi Minh City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.
Status | Completed |
Enrollment | 183 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients diagnosed with periampullary cancer meet the following criteria: - Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration. - The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas) Exclusion Criteria: - The patient has other organ's cancer beyond periampullary cancer. - Patient's medical conditions contraindicate for anesthesia. - The patient does not consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
Vietnam | Phan Minh Tri | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Vo Truong Quoc |
Vietnam,
Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery A — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pancreatic fistula | Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula | 90 post-operative days | |
Secondary | Bleeding complication | Rate and location of post-operative bleeding, risk factors relate to this complication | 90 post-operative days |
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