NCT05703581

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

January 19, 2023

Last Update Submit

July 28, 2023

Conditions

PancreatoduodenectomyPeriampullary CarcinomaPancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival (RFS)

    from the date of surgery to the first radiographic or pathologic evidence of recurrence.

    up to 72 months

Secondary Outcomes (2)

  • Overall survival (OS)

    up to 72 months

  • Surgical Morbidity

    90 postoperative days

Study Arms (4)

PD(TRIANGLE)

Patients with pancreatic head cancer or periampullary cancer underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy

Procedure: TRIANGLE operation

PD(non-TRIANGLE)

Patients with pancreatic head cancer or periampullary cancer underwent pancreatoduodenectomy with standard lymphadenectomy

DP(TRIANGLE)

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

DP(non-TRIANGLE)

Patients with carcinoma of the body and tail of the pancreas underwent distal pancreatectomy with standard lymphadenectomy

Interventions

TRIANGLE operationPROCEDURE

dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)

DP(TRIANGLE)PD(TRIANGLE)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huadong Hospital affiliated to Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Chongyi Jiang, PhD

    Huadong Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chongyi Jiang, PhD

CONTACT

+86-18101802916jiangzhongyi9@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)