Neoplasms

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Carcinoma, Pancreatic Ductal

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Neoplasms

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Gastrointestinal Diseases

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Pancreatic Cancer

In addition to the standard lymphadenectomy, the nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1) must be dissected. Retroperitoneal lymphatic tissue, nerves and connective tissue range from the hepatic portal down to the beginning part of the inferior mesenteric artery, the right to the right renal hilus, left to the left edge of the abdominal aorta is included.

Lymph node dissection includes the superior and inferior pyloric nodes (LN5, LN6), anterior and posterior nodes along the common hepatic artery (CHA) (LN8a, 8b), nodes along the common hepatic duct, common bile duct and cystic duct (LN12b1, 12b2, 12c), posterior pancreatoduodenal nodes (LN13a, 13b), nodes along the superior mesenteric artery (SMA) (LN14a, 14b), anterior pancreatoduodenal nodes (LN17a, 17b), but excluding the nerve tissues around common hepatic artery and the superior mesenteric artery.

Extended lymphadenectomy with nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1)

Extended lymphadenectomy

Lymph node dissection includes(LN5, LN6),(LN8a, 8b),(LN12b1, 12b2, 12c),(LN13a, 13b),(LN14a, 14b),(LN17a, 17b)

Standard lymphadenectomy

Xubao Liu, MD

Junjie Xiong, MD

Hongyu Chen, MD

Nengwen Ke, MD

Chunlu Tan, MD

Hao Zhang, MD

Ming Yang, MD

Bole Tian, MD

Weiming Hu, MD

Kezhou Li, MD

The aim of this study is to determine whether the performance of extended lymphadenectomy in association with pancreatoduodenectomy improves the long-term survival in patients with pancreatic head ductal adenocarcinoma.Half of participants will receive pancreatoduodenectomy with extended lymphadenectomy,while the other half will receive pancreatoduodenectomy with standard lymphadenectomy.

Pancreatic cancer is a common malignant disease of the digestive system, and its incidence has been steadily increasing recently. Currently, the only potential curative treatment for pancreatic cancer is radical surgery. However, due to the peculiarity of the anatomical location of pancreas (in the retroperitoneum, surrounded by peripheral nerves and blood vessels) and its biological characteristics (neurotropic, highly malignant, and with probable skip metastasis), it is difficult to achieve R0 resection in patients with pancreatic cancer. High postoperative recurrence and distant metastasis rate are key factors in reducing long-term survival of patients with pancreatic cancer. The radical surgery modalities for pancreatoduodenectomy to achieve R0 resection involve extended lymphadenectomy, multivisceral resections, with or without simultaneous vein removals. Currently, the lymphadenectomy extent and approaches used to achieve R0 status are diverse. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) reached a consensus to strive to resect lymph nodes (LNs) 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b in standard lymphadenectomy for pancreatoduodenectomy. However, no consensus was reached on dissection of LN 16 due to variation in the literature and different expert opinions. On the current evidence, benefit of extended lymph node dissection seems to be outweighed by the risks. But deficiencies exist in the design of previous RCTs, such as insufficient sample size, lack of certain critical data for statistical analysis, inclusion of other pathological types of pancreatic neoplasms and variable retroperitoneal lymph node resection and nerve plexus dissection . Therefore, the power of evidence was low. Most studies report a high frequency of lymph node metastasis to LNs 13, 14, 17, 12 and 16 in pancreatic cancer, and tendency to metastasis from LNs 13, 14 to LN 16. In a lot of case reports, only nodal station 16a2 and 16b1 were positive in LN 16.

This study is performed to confirm whether pancreatoduodenectomy with extended lymphadenectomy could improve survival. Subjects undergoing surgery will be randomized to pancreatoduodenectomy with extended lymphadenectomy including nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1) versus standard pancreatoduodenectomy. Subjects will be followed every three months for survivorship or death. The primary endpoint of 5-year overall or disease-free survival survival will be determined at five year post surgery.

Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma

Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy

The percentage of patients that are alive at a 5 year

Presence of fever, signs of peritonitis, high leukocytes count or positive peritoneal drainage fluid culture

Requiring invasive treatment, for example: positive wound exudate culture and requiring continuous re-open drainage or invasive treatment

Death due to any cause before or at postoperative day 30 and 60

EORTC QLQ-C30, according to the scoring manual published by the EORTC Quality of Life group

The percentage of patients alive without recurrence at a 5 year

Royal Liverpool University Hospital

West China Hospital

Hongyu Chen,MD

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

Professor

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.

Overall Study

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Pancrelipase

Pancreatin

Kava

Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction

In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava).

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes

Extended Lymphadenectomy

Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes

Standard Lymphadenectomy

Jiancheng WANG, Dr

The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.

Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.

Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer

pancreatic fistula, bile leakage, haemorrhage, DGE, etc

1, 3 \& 5 years disease free survival rate

Ruijin Hospital

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed

Field 5 (Group external iliac rigt) Field 7 (Group external iliac left) Field 9 (obturatorical Group right) Field 11 (obturatorical Group left) Field 13 (Group internal iliac right) Field 14 (Group internal iliac left)

limited lymphadenectomy

Field 1 (paracaval right) Field 2 (interaortocaval) Field 3 (paraaortal left) Field 4 (Group iliac artery right) Field 5 (Group external iliac rigt) Field 6 (Group iliac artery left) Field 7 (Group external iliac left) Field 8 (presacral) Field 9 (obturatorical Group right) Field 10 (deep obturatorical Group right) Field 11 (obturatorical Group left) Field 12 (deep obturatorical Group left) Field 13 (Group internal iliac right) Field 14 (Group internal iliac left)

extended lymphadenectomy

Jürgen E. Gschwend, Prof. Dr.

This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.

The extent of pelvic lymphadenectomy in the surgical treatment of muscle-invasive, clinically locally bladder cancer is not yet standardized. There are no data from randomized, prospective studies on the prognostic role of regional lymphadenectomy.

Results of retrospective studies suggest, that the prognosis of patients with muscle-invasive bladder cancer can be improved by extending the limits of pelvic lymphadenectomy. Furthermore it could be demonstrated in a prospective study that the pattern of metastasis of bladder cancer has a high variability. About two-thirds of lymph node metastases are found outside the normally cleared areas of lymphadenectomy. In this study patients will be randomized into arms with limited versus extended lymphadenectomy.

The limited lymphadenectomy includes the removal of the obturatoric, external and internal iliac lymph nodes, the extended one includes the removal of all lymph nodes between pelvic floor and the inferior mesenteric artery. The primary objective of the study is to detemine the influence of limited versus extended lyphadenectomy at the time of radical cystectomy on recurrence-free survival. Secondary study objectives include the influence on cancer-specific survival, overall survival, complication rates, histopathologic N-stage, the localization of recurrence and influence of adjuvant chemotherapy . Adjuvant chemotherapy is optional and is recommended in patients with locally advanced disease (pT3/4) or regional lymph node metastasis (pN+).

Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms

Definition Recurrence-free survival: Time from radical cystectomy to tumor reccurence or death from any cause up to 5 years

Definition Cancer-specific suvival: Time from radical cystectomy to death from bladder cancer up to 5 years

Definition Overall survival: Time from radical cystectomy to death from any cause up to 5 years

Definition Effect on histopathologic stage: Influence of extended lymphadenectomy on detection of lymph node metastasis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma	NCT02928081	Carcinoma, Panc...	Extended lympha... Standard lympha...	18 Years - 75 Years	West China Hospital
Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma	NCT02928081	Carcinoma, Panc...	Extended lympha... Standard lympha...	18 Years - 75 Years	West China Hospital
Standardization of Surgery on the Pancreatic Cancer	NCT00679913	Pancreatic Canc...	Standard pancre... Extended pancre...	20 Years - 85 Years	Seoul National University Hospital
Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.	NCT04115527	Pancreatic Duct...	Extended Lympha... Standard Lympha...	18 Years - 70 Years	Ruijin Hospital
Standard Versus Extended Lymphadenectomy in Pancreatoduodenectomy for Patients With Pancreatic Head Adenocarcinoma	NCT02928081	Carcinoma, Panc...	Extended lympha... Standard lympha...	18 Years - 75 Years	West China Hospital
Standardization of Surgery on the Pancreatic Cancer	NCT00679913	Pancreatic Canc...	Standard pancre... Extended pancre...	20 Years - 85 Years	Seoul National University Hospital
Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA	NCT01215071	Bladder Cancer	limited lymphad... extended lympha...	18 Years -	Association of Urologic Oncology (AUO)

Spots Global Cancer Trial Database for extended lymphadenectomy