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

NCT ID: NCT01291927

Last Updated: 2011-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2015-05-31

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.

Conditions

Periampullary Carcinoma Nos

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pancreas-sparing duodenectomy

Group Type: EXPERIMENTAL

Pancreas-sparing duodenectomy

Intervention Type: PROCEDURE

Pancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society (JPS) system for numbering of lymph node stations was adopted for accurate description of the surgery and pathological assessment.The standard lymph node groups removed as part of PSD were the anterior pancreatoduodenal groups (JPS LN17), the posterior pancreatoduodenal groups (JPS LN13), the dextroinferior nodes of the hepatoduodenal ligament node groups (JPS LN12), the infrapyloric node (JPS LN6), the nodes around the anterior aspect of the common hepatic artery (JPS LN8) and the nodes on the right side of the SMA (JPS LN14).

Pancreaticoduodenectomy

Group Type: ACTIVE_COMPARATOR

Pancreaticoduodenectomy

Intervention Type: PROCEDURE

The surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the proximal hepatic artery.

Interventions

Pancreas-sparing duodenectomy

Pancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society (JPS) system for numbering of lymph node stations was adopted for accurate description of the surgery and pathological assessment.The standard lymph node groups removed as part of PSD were the anterior pancreatoduodenal groups (JPS LN17), the posterior pancreatoduodenal groups (JPS LN13), the dextroinferior nodes of the hepatoduodenal ligament node groups (JPS LN12), the infrapyloric node (JPS LN6), the nodes around the anterior aspect of the common hepatic artery (JPS LN8) and the nodes on the right side of the SMA (JPS LN14).

Intervention Type: PROCEDURE

Pancreaticoduodenectomy

The surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the proximal hepatic artery.

Intervention Type: PROCEDURE

Other Intervention Names

PSD; PD

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Institute of Hepatobiliary Surgery, Southwest Hospital ,Third Military Medical University

Principal Investigators

Ping Bie, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

Geng Chen, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

Locations

Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Geng Chen, M.D.,Ph.D.

Role: CONTACT

chengeng@medmail.com.cn

86-0-13996418308

Facility Contacts

Geng Chen, M.D.,Ph.D.

Role: primary

chengeng@medmail.com.cn

86-0-13996418308

Other Identifiers

HBS-PSU-001

Identifier Type: -

Identifier Source: org_study_id