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

February 8, 2011 updated by: Southwest Hospital, China

Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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 (JPS) system for numbering of lymph node stations was adopted for accurate description of the surgery and pathological assessment.The standard lymph node groups removed as part of PSD were the anterior pancreatoduodenal groups (JPS LN17), the posterior pancreatoduodenal groups (JPS LN13), the dextroinferior nodes of the hepatoduodenal ligament node groups (JPS LN12), the infrapyloric node (JPS LN6), the nodes around the anterior aspect of the common hepatic artery (JPS LN8) and the nodes on the right side of the SMA (JPS LN14).
Other Names:
  • PSD
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 proximal hepatic artery.
Other Names:
  • PD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Southwest Hospital, China

Investigators

  • Study Director: Ping Bie, M.D.,Ph.D., Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
  • Principal Investigator: Geng Chen, M.D.,Ph.D., Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

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 Major Dates

Study Start

May 1, 2005

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

February 8, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2011

Last Update Submitted That Met QC Criteria

February 8, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBS-PSU-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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