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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01291927
Recruitment Status : Unknown
Verified January 2011 by Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : February 9, 2011
Last Update Posted : February 9, 2011
Information provided by:
Southwest Hospital, China

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

Condition or disease Intervention/treatment Phase
Periampullary Carcinoma Nos Procedure: Pancreas-sparing duodenectomy Procedure: Pancreaticoduodenectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
Study Start Date : May 2005
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

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U.S. FDA Resources

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 Name: 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 Name: PD

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
    It is an average time peroid.

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01291927

Contact: Geng Chen, M.D.,Ph.D. 86-0-13996418308

China, Chongqing
Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: Geng Chen, M.D.,Ph.D.    86-0-13996418308   
Sponsors and Collaborators
Southwest Hospital, China
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

Responsible Party: Institute of Hepatobiliary Surgery, Southwest Hospital (Ping Bie), Institute of Hepatobiliary Surgery, Southwest Hospital ,Third Military Medical University Identifier: NCT01291927     History of Changes
Other Study ID Numbers: HBS-PSU-001
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: January 2011

Keywords provided by Southwest Hospital, China:
Periampullary carcinoma
Pancreas-sparing Duodenectomy

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Agents