Clinical trial NCT01291927: Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma
Official title: Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periampullary Carcinoma Nos
Keywords: Periampullary carcinoma
Pancreas-sparing Duodenectomy
pancreaticoduodenectomy
lymphadenectomy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: Number of Patients with early postoperative complications as a Measure of Safety and Tolerability
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University
state: Chongqing
Study officials:
affiliation: Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
name: Ping Bie, M.D.,Ph.D.
role: STUDY_DIRECTOR
affiliation: Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
name: Geng Chen, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: