Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy For Early-stage Periampullary Carcinoma

Study Overview

Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma

The purpose of this study is to investigate the feasibility, safety, and long-term prognosis of pancreas-sparing duodenectomy with regional lymphadenectomy in the treatment of early-stage (pTis/pT1/pT2) periampullary carcinoma with or without lymph node metastasis

Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent years, morbidity and mortality rates following PD have decreased, but the operative stress induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for PC without pancreatic and diffuse lymph node involvement. From the perspective of organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive option for selected periampullary tumors, and offers an alternative to PD. Previous reports have described PSD for benign, premalignant and some selected malignant conditions of duodenum, and have emphasized this procedure as a safe and effective treatment associated with good quality of life. However, use of PSD for PC is still controversial.Available data about PSD for PC and published data from the follow-up evaluation in the literature are still limited. Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional lymph node dissection should be essential for PC. However, lymphadenectomy has never been promoted as a regular procedure of PSD.The aim of the present study was to investigate the feasibility, safety, and long-term results of PSD with regional lymphadenectomy for early-stage (pTis/pT1/pT2) periampullary cancers.

Periampullary Carcinoma Nos

PROCEDURE: Pancreas-sparing duodenectomy
PROCEDURE: Pancreaticoduodenectomy

HBS-PSU-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-02-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-02-08
First Submitted that Met QC Criteria 2011-02-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-02-09
First Posted (ESTIMATED) 2011-02-09	Results First Posted N/A	Last Verified 2011-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pancreas-sparing duodenectomy	PROCEDURE: Pancreas-sparing duodenectomy Pancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society
ACTIVE_COMPARATOR: Pancreaticoduodenectomy	PROCEDURE: Pancreaticoduodenectomy The surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the pr

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pancreas-sparing duodenectomy

PROCEDURE: Pancreas-sparing duodenectomy

Pancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society

ACTIVE_COMPARATOR: Pancreaticoduodenectomy

PROCEDURE: Pancreaticoduodenectomy

The surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the pr

Primary Outcome Measures	Measure Description	Time Frame
Disease free survival	It is an average time peroid.	5 years

Secondary Outcome Measures	Measure Description	Time Frame
Number of Patients with early postoperative complications as a Measure of Safety and Tolerability	Early postoperative complications consist of gastrointestinal/abdominal bleeding, pancreatic leakage, encephalopathy, delayed gastric emptying, diabetes mellitus and wound infection	up to 2 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Geng Chen, M.D.,Ph.D.

Phone Number: 86-0-13996418308

Email: chengeng@medmail.com.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pathologically proven periampullary carcinoma (including cancers of distal common bile duct, ampulla or papilla of Vater)
Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0
ASA score: < 3
Liver function:Child-Pugh A
No history of other cancers
No history of preoperative chemotherapy or radiotherapy
Written informed consent

There are concurrent cancers or the patients have been treated due to other type of cancers before diagnosed as periampullary carcinoma
Pre- and intra-operative stage: more advanced than T2,or with remote metastasis
The Patients received other non-surgical therapy, such as chemotherapy, immunotherapy, radiotherapy or endoscopic therapy
The Patients received upper abdominal surgery
ASA score: ≥ 3
Liver function:Child-Pugh B or C
Pregnancy patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Ping Bie, M.D.,Ph.D., Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record