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

Not Applicable

• Conditions: Periampullary Carcinoma Nos
• Interventions: Procedure: Pancreas-sparing duodenectomy; Procedure: Pancreaticoduodenectomy

• Registration Number: NCT01291927
• Lead Sponsor: Southwest Hospital, China

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.

Study Timeline

• Study Start: 2005-05
• Status Verified: 2011-01
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-08
• Last Update Submitted: 2011-02-08
• Study First Posted: 2011-02-09
• Last Update Posted: 2011-02-09
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreas-sparing duodenectomy	Pancreas-sparing duodenectomy	-
Pancreaticoduodenectomy	Pancreaticoduodenectomy	-

Primary Outcome Measures

Name	Time	Method
Disease free survival	5 years	It is an average time peroid.

Secondary Outcome Measures

Name	Time	Method
Number of Patients with early postoperative complications as a Measure of Safety and Tolerability	up to 2 weeks	Early postoperative complications consist of gastrointestinal/abdominal bleeding, pancreatic leakage, encephalopathy, delayed gastric emptying, diabetes mellitus and wound infection

Trial Locations

Locations (1)

Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China