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

Army Medical University

Status

Unknown

Conditions

Periampullary Carcinoma Nos

Treatments

Procedure: Pancreaticoduodenectomy

Procedure: Pancreas-sparing duodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01291927

HBS-PSU-001

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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