Standardization of Surgery on the Pancreatic Cancer

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Standard pancreatoduodenectomy; Procedure: Extended pancreatoduodenectomy

• Registration Number: NCT00679913
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-19
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Results First Submitted: 2014-04-07
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-08
• Last Update Submitted: 2014-05-08
• Results First Posted: 2014-06-06
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard pancreatoduodenectomy	standard pancreatoduodenectomy
2	Extended pancreatoduodenectomy	extended pancreatoduodenectomy

Primary Outcome Measures

Name	Time	Method
Survival	2 year after surgery	comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery

Secondary Outcome Measures

Name	Time	Method
Morbidity	within 2 years after surgery	Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of