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

This study is currently recruiting participants.
Verified January 2011 by Southwest Hospital, China
Sponsor:
Information provided by:
Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01291927
First received: February 8, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention
Periampullary Carcinoma Nos
 Procedure: Pancreas-sparing duodenectomy
Procedure: Pancreaticoduodenectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    It is an average time peroid.


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


Estimated Enrollment: 120
Study Start Date: May 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291927

Contacts
Contact: Geng Chen, M.D.,Ph.D. 86-0-13996418308 chengeng@medmail.com.cn

Locations
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     chengeng@medmail.com.cn    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Institute of Hepatobiliary Surgery, Southwest Hospital (Ping Bie), Institute of Hepatobiliary Surgery, Southwest Hospital ,Third Military Medical University
ClinicalTrials.gov Identifier: NCT01291927     History of Changes
Other Study ID Numbers: HBS-PSU-001
Study First Received: February 8, 2011
Last Updated: February 8, 2011
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatin
 Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013