Pancreatic Cancer Clinical Trial
Official title:
Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
Aim of the study : To evaluate the effect and safety of "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer . Methods : Patients who underwent pancreatoduodenectomy or Distal Pancreatectomy between 01 September 2016 and 30 December 2022 will be included in this retrospective analysis. 3D reconstruction is performed with preoperative enhanced CT, then the region of "Heidelberg Triangle" is categorized . The operation is completed by the same operation team. According to the operation mode, patients were divided into TRIANGLE group and non-TRIANGLE group and And followed up until recurrence, death or missed.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation. 2. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery. 3. Be able to comply with the research visit plan and other program requirements Exclusion Criteria: 1. Patients accompanied by other systemic malignancies. 2. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery. 3. Pregnant and lactating women. 4. Any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities. |
Country | Name | City | State |
---|---|---|---|
China | Huadong Hospital affiliated to Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence free survival (RFS) | from the date of surgery to the first radiographic or pathologic evidence of recurrence. | up to 72 months | |
Secondary | Overall survival (OS) | from the date of diagnosis to death or last follow up | up to 72 months | |
Secondary | Surgical Morbidity | including postoperative pancreatic fistula (B/C), bile leakage (B/C), delayed gastric emptying (B/C), postpancreatectomy haemorrhage (B/C), postoperative chyle leak (B/C), postoperative intra-abdominal infection. | 90 postoperative days |
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