Application of Heidelberg Triangle Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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The Heidelberg Triangle is an anatomical area composed of Common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV). This area is considered to be the common site of recurrence after pancreatic surgery. Recent studies have shown that TRIANGLE operation can improve the state of the cutting edge and has potential value in improving the prognosis. However, the data on recurrence and survival rate of pancreatic cancer and periampullary cancer after TRIANGLE operation are insufficient. The aim of the present study is to evaluate the effect and safety of Heidelberg Triangle dissection combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .

Official Title
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Application of Heidelberg Triangle Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

Conditions
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Pancreatoduodenectomy, Periampullary Carcinoma, Pancreatic Cancer

Intervention / Treatment
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* Procedure: TRIANGLE operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery. Be able to comply with the research visit plan and other program requirements Exclusion Criteria: Patients accompanied by other systemic malignancies. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery. Pregnant and lactating women. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD(TRIANGLE)<br>Patients with pancreatic head cancer or periampullary cancer underwent Heidelberg Triangle dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy | Procedure: TRIANGLE operation<br>* dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)<br>|
| PD(non-TRIANGLE)<br>Patients with pancreatic head cancer or periampullary cancer underwent pancreatoduodenectomy with standard lymphadenectomy | |
| DP(TRIANGLE)<br>Patients with carcinoma of the body and tail of the pancreas underwent Heidelberg Triangle dissection (TRIANGLE operation) combined with distal pancreatectomy and standard lymphadenectomy | Procedure: TRIANGLE operation<br>* dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)<br>|
| DP(non-TRIANGLE)<br>Patients with carcinoma of the body and tail of the pancreas underwent distal pancreatectomy with standard lymphadenectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival (RFS) | from the date of surgery to the first radiographic or pathologic evidence of recurrence. | up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | from the date of diagnosis to death or last follow up | up to 72 months | 
| 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 |