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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.
The investigator will conduct this study at both site at the same time: Cho Ray Hospital and University and Pharmacy Center. The investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. The investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications.
Plan for conducting the study:
Data analysis
Sample size:
• The investigator expect approximately 100 patients in the first year in both centers. And the investigator hope at least 110 patients in the whole conducting time.
Plan for missing data:
• The investigator will directly collect the patient information before the operation, observe the operation process and follow-up the postoperative during. Investigator will remove any case that missing preoperative information, operative data or post-operative laboratory test.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreaticoduodenectomy | Procedure | Patient with periampullary cancer will be underwent pancreaticoduodenectomy in 2 types of pancreatic-jejunal anastomosis reconstructions. We describe the postoperative complications (pancreatic fistula and bleeding) and analysis the risk factors relate to those complications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic fistula | Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula | 90 post-operative days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding complication | Rate and location of post-operative bleeding, risk factors relate to this complication | 90 post-operative days |
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Inclusion Criteria:
Patients diagnosed with periampullary cancer meet the following criteria:
Exclusion Criteria:
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Patients diagnosed with periampullary cancer will be underwent pancreaticoduodenectomy and will be followed-up after operation.
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| Name | Affiliation | Role |
|---|---|---|
| TruongQuoc Vo, Doctor | University of Medicine and Pharmacy at HoChiMinh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phan Minh Tri | Ho Chi Minh City | 700000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32161987 | Result | 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 After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w. |
| Label | URL |
|---|---|
| Guidelines for Perioperative Care for Pancreaticoduodenectomy | View source |
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The IPD will be saved as a excel and spss file (with a password to open). This data can be shared with other researchers if needed.
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |