Standardization of Surgery on the Pancreatic Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

NCT02479984

Pancreatic Cancer

UNKNOWN NA

Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer

NCT05703139

Hepato-Biliary Precancerous Condition

RECRUITING

Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

NCT06135649

Pancreas Cancer Pancreatic Adenocarcinoma

RECRUITING

In This Study, a Retrospective Analysis Was Conducted to Explore the Risk Factors for Patients Undergoing Pancreaticoduodenal Surgery (PD) to Achieve TO, and a Nomogram Prediction Model Was Further Established to Promote the Standardization and Standardization of PD Surgical Quality Evaluation.

NCT06763250

Pancreatic Carcinoma Cholangiocarcinoma Pancreaticoduodenectomy

RECRUITING

Evaluation of Resection Techniques for Pancreatic Tumors

NCT05128890

Surgery Liver Tumor Pancreas Tumor

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

standard pancreatoduodenectomy

Group Type ACTIVE_COMPARATOR

Standard pancreatoduodenectomy

Intervention Type PROCEDURE

Standard pancreatoduodenectomy

2

extended pancreatoduodenectomy

Group Type ACTIVE_COMPARATOR

Extended pancreatoduodenectomy

Intervention Type PROCEDURE

Extended pancreatoduodenectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard pancreatoduodenectomy

Intervention Type PROCEDURE

Extended pancreatoduodenectomy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Extended lymphadenectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age : 20- 85 years old
* No evidence of metastasis and to be possible to resect radically
* No history of previous radiation therapy or chemotherapy
* Pathological diagnosis: adenocarcinoma of pancreas
* Patients who agree and sign the informed consent
* More than 70 in Karnofsky performance scale

Exclusion Criteria

* Past medical history of treatment for other malignant disease
* Recurred pancreatic cancer patients
* Patients with R1/R2 resection
* Patients who underwent neoadjuvant chemotherapy

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No