Clinical trial NCT05703581: Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
Official title: Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatoduodenectomy
Periampullary Carcinoma
Pancreatic Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent undergo pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation

Brief summary: 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: 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence free survival (RFS)
timeFrame: up to 72 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 72 months
measure: Surgical Morbidity
timeFrame: 90 postoperative days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong Hospital affiliated to Fudan University
Study officials:
affiliation: Huadong Hospital
name: Chongyi Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: