Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma
Recruitment status was Recruiting
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
Periampullary Carcinoma Nos
Procedure: Pancreas-sparing duodenectomy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial|
- Disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]It is an average time peroid.
- Number of Patients with early postoperative complications as a Measure of Safety and Tolerability [ Time Frame: up to 2 weeks ] [ Designated as safety issue: Yes ]Early postoperative complications consist of gastrointestinal/abdominal bleeding, pancreatic leakage, encephalopathy, delayed gastric emptying, diabetes mellitus and wound infection
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Pancreas-sparing duodenectomy||
Procedure: 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).
Other Name: PSD
|Active Comparator: 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.
Other Name: PD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291927
|Contact: Geng Chen, M.D.,Ph.D.||email@example.com|
|Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University||Recruiting|
|Chongqing, Chongqing, China, 400038|
|Contact: Geng Chen, M.D.,Ph.D. 86-0-13996418308 firstname.lastname@example.org|
|Study Director:||Ping Bie, M.D.,Ph.D.||Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University|
|Principal Investigator:||Geng Chen, M.D.,Ph.D.||Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University|