Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

Recruiting

• Conditions: Periampullary Carcinoma; Pancreatoduodenectomy; Pancreatic Cancer
• Interventions: Procedure: TRIANGLE operation

• Registration Number: NCT05703581
• Lead Sponsor: Fudan University

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 .

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-30
• Study Start: 2023-03-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD(TRIANGLE)	TRIANGLE operation	Patients with pancreatic head cancer or periampullary cancer underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy
DP(TRIANGLE)	TRIANGLE operation	Patients with carcinoma of the body and tail of the pancreas underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with distal pancreatectomy and standard lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Recurrence free survival (RFS)	up to 72 months	from the date of surgery to the first radiographic or pathologic evidence of recurrence.

Secondary Outcome Measures

Name	Time	Method
Surgical Morbidity	90 postoperative days	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.
Overall survival (OS)	up to 72 months	from the date of diagnosis to death or last follow up

Trial Locations

Locations (1)

Huadong Hospital affiliated to Fudan University; 🇨🇳 Shanghai, China