Periampullary Carcinoma Nos Clinical Trial
Official title:
Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
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
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01468779 -
Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms
|
Phase 3 |