NCT01291927

Brief Summary

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

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 9, 2011

Status Verified

January 1, 2011

Enrollment Period

10 years

First QC Date

February 8, 2011

Last Update Submit

February 8, 2011

Conditions

Periampullary Carcinoma Nos

Keywords

Periampullary carcinomaPancreas-sparing Duodenectomypancreaticoduodenectomylymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    It is an average time peroid.

    5 years

Secondary Outcomes (1)

  • Number of Patients with early postoperative complications as a Measure of Safety and Tolerability

    up to 2 weeks

Study Arms (2)

Pancreas-sparing duodenectomy

EXPERIMENTAL
Procedure: Pancreas-sparing duodenectomy

Pancreaticoduodenectomy

ACTIVE COMPARATOR
Procedure: Pancreaticoduodenectomy

Interventions

Pancreas-sparing duodenectomyPROCEDURE

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).

Also known as: PSD
Pancreas-sparing duodenectomy
PancreaticoduodenectomyPROCEDURE

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.

Also known as: PD
Pancreaticoduodenectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ping Bie, M.D.,Ph.D.

    Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

    STUDY DIRECTOR

  • Geng Chen, M.D.,Ph.D.

    Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geng Chen, M.D.,Ph.D.

CONTACT

86-0-13996418308chengeng@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

May 1, 2005

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 9, 2011

Record last verified: 2011-01

Locations

CN(1)