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Resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).

Standard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).

resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy

standard pancreatoduodenectomy

Xianjun Yu, M.D., Ph.D

Yu Lu

Xianjun Yu, M.D

This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

Lymph node metastasis and nerve invasion are characteristics of pancreatic cancer. For pancreatic head cancer, celiac and SMA nerve plexus are often involved. Many surgeons started to improve the surgical approach of pancreatoduodenectomy by extending the extent of surgical resection including an extended lymph node dissection and nerve plexus clearance in the hope of achieving better long-term survival rate. Postoperative complications such as diarrhea and malnutrition were reported after celiac and SMA nerve plexus resection during pancreatoduodenectomy. As a result, resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy was recommended. This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

Subjects undergoing surgery will be randomized to extended pancreatoduodenectomy with resection of the nerve plexus on the right half of celiac and SMA versus standard pancreatoduodenectomy. Subjects will be followed every two months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of overall survival and the secondary endpoint of disease-specific free survival will be determined at two year post surgery.

Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas

Pain control will be assess by the Visual Analogue Scale (VAS)

Fudan University

Professor

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Standard pancreatoduodenectomy

Extended pancreatoduodenectomy

Sun-Whe Kim, MD., PhD.

This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

Standardization of Surgery on the Pancreatic Cancer

Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery

Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy

Seoul National University Hospital

standard pancreatoduodenectomy

Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA).

Standard Pancreatoduodenectomy

extended pancreatoduodenectomy

Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized.

Extended Pancreatoduodenectomy

extended pancreatoduodenectomy

Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.

Total

Age, Continuous

Sex: Female, Male

Sun-Whe Kim, M.D., Ph.D., FACS

Survival

extended pancreatoduodenectomy

Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized

Morbidity

standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)

extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas	NCT02514928	Pancreatic Canc...	resection of th... standard pancre...	18 Years - 80 Years	Fudan University
Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas	NCT02514928	Pancreatic Canc...	resection of th... standard pancre...	18 Years - 80 Years	Fudan University
Standardization of Surgery on the Pancreatic Cancer	NCT00679913	Pancreatic Canc...	Standard pancre... Extended pancre...	20 Years - 85 Years	Seoul National University Hospital
Standardization of Surgery on the Pancreatic Cancer	NCT00679913	Pancreatic Canc...	Standard pancre... Extended pancre...	20 Years - 85 Years	Seoul National University Hospital

Spots Global Cancer Trial Database for standard pancreatoduodenectomy