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

Primary Purpose

Periampullary Carcinoma Nos

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pancreas-sparing duodenectomy
Pancreaticoduodenectomy
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periampullary Carcinoma Nos focused on measuring Periampullary carcinoma, Pancreas-sparing Duodenectomy, pancreaticoduodenectomy, lymphadenectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pancreas-sparing duodenectomy

Pancreaticoduodenectomy

Arm Description

Outcomes

Primary Outcome Measures

Disease free survival
It is an average time peroid.

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2011
Last Updated
February 8, 2011
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01291927
Brief Title
Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma
Official Title
Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Carcinoma Nos
Keywords
Periampullary carcinoma, Pancreas-sparing Duodenectomy, pancreaticoduodenectomy, lymphadenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pancreas-sparing duodenectomy
Arm Type
Experimental
Arm Title
Pancreaticoduodenectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Pancreas-sparing duodenectomy
Other Intervention Name(s)
PSD
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Pancreaticoduodenectomy
Other Intervention Name(s)
PD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease free survival
Description
It is an average time peroid.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Patients with early postoperative complications as a Measure of Safety and Tolerability
Description
Early postoperative complications consist of gastrointestinal/abdominal bleeding, pancreatic leakage, encephalopathy, delayed gastric emptying, diabetes mellitus and wound infection
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geng Chen, M.D.,Ph.D.
Phone
86-0-13996418308
Email
chengeng@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Bie, M.D.,Ph.D.
Organizational Affiliation
Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Geng Chen, M.D.,Ph.D.
Organizational Affiliation
Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geng Chen, M.D.,Ph.D.
Phone
86-0-13996418308
Email
chengeng@medmail.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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