Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
18 Years
80 Years
Both
Periampullary Carcinoma Nos
Trial Information
Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease free survival
Outcome Description:
It is an average time peroid.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Ping Bie, M.D.,Ph.D.
Investigator Role:
Study Director
Investigator Affiliation:
Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
Authority:
China: Ethics Committee
Study ID:
HBS-PSU-001
NCT ID:
NCT01291927
Start Date:
May 2005
Completion Date:
May 2015
Related Keywords:
- Periampullary Carcinoma Nos
- Periampullary carcinoma
- Pancreas-sparing Duodenectomy
- pancreaticoduodenectomy
- lymphadenectomy
- Carcinoma
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