Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Anesthetics

Liver Extracts

Laparoscopic pancreaticoduodenectomy Under general anesthesia, the patient is placed in a supine position with the legs abducted. Carbon dioxide pneumoperitoneum is established using an open technique through a 10-mm trocar over the umbilicus. A 30 telescope is inserted to examine the peritoneal cavity, liver, stomach, and mesentric vessels.Then 4 to 6 more trocars are inserted under direct vision in the epigastrium and upper quadrants

1. dissection
2. reconstruction

Open pancreaticoduodenectomy Abdomen is opened from the Bilateral Subcostal incision. (Chevron's Incision) 2. Abdominal cavity is explored for metastasis especially in liver, base of mesentary, mesocolon and pelvis.

Dissection Reconstruction Pancreaticogastrostomy Hepaticojejunostomy is next- Done in single layer and can be performed in interrupted or continuous fashion.

Gastrojejunostomy is the final step of reconstruction.

Laparoscopic pancreaticoduodenectomy

1. dissection
2. reconstruction

Laparoscopic pancreaticoduodenectomy

Open pancreaticoduodenectomy

Ayman El Nakeeb, MD

Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care. Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD.

Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care . Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited despite several improvements in surgical devices and techniques that have allowed surgeons to approach the pancreas laparoscopically, laparoscopic PD remains challenging. LPD represents one of the most advanced abdominal operations owing to the necessity of a complex dissection and reconstruction. Recent reports note that complete laparoscopic PD including laparoscopic resection and reconstruction is both technically feasible and safe. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD

Minimally Invasive Pancreatico-duodenectomy

Comparative Study Between Minimally Invasive Pancreatico-duodenectomy and Open Pancreatico-duodenectomy for Periampullary Tumors

Postoperative pancreatic ﬁstula was defined as proposed by the international study group of pancreatic ﬁstula (ISGPF) as any measurable volume of ﬂuid on or after postoperative day (POD) 3 with amylase content greater than 3 times the serum amylase activity, and classified into grades A, B, C .

Mansoura University

Gastroenterology surgical center, mansoura university

Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

laparoscopic pancreaticoduodenectomy

open pancreaticoduodenectomy

Hang Zhang

Renyi Qin

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Share only when contact to Principal Investigator

defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death

Fudan University

Shanxi Province Cancer Hospital

The Second Affiliated Hospital of Chongqing Medical University

The First Hospital of Jilin University

The Second Hospital of Hebei Medical University

The First Affiliated Hospital of Dalian Medical University

The Third Affiliated Hospital of Soochow University

The Affiliated Hospital of Xuzhou Medical University

Chongqing University Cancer Hospital

Hunan Provincial People's Hospital

Tongji Hospital

Prof

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Bile Duct Diseases

Common Bile Duct Diseases

Gastrointestinal Diseases

Biliary Tract Diseases

Pancreatic Cancer

The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.

The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.

Robot Pancreaticoduodenectomy

Guodong Chen, PhD

Danjun Chen, PhD

laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on their perioperative safety and prognostic effects.However, there are few studies on the perioperative safety and prognostic effects of both procedures. In this trial, the perioperative data and prognosis of both procedures were collected and analyzed through a prospective, multicenter approach to investigate the advantages and disadvantages of both procedures.

In this trial, subjects proposed for PD were randomly divided into two groups, LPD and RPD, according to inclusion and exclusion criteria. Patients in both groups were operated and received perioperative management under the same surgical team and were operated according to the standard PD surgical approach. Subsequently, perioperative clinical data and long-term prognostic data of subjects in both groups will be collected and statistically analyzed to explore a better surgical approach.

The key difference in treatment between the two groups is the surgical approach, with the LPD group undergoing laparoscopic-assisted pancreaticoduodenectomy and the RPD group undergoing robotic-assisted pancreaticoduodenectomy, with all treatments remaining the same except for the surgical approach.

A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy

Survival will be documented 3 years after surgery

Serious discomfort requiring re-admission within 30 days after discharge will be recorded, and the safety of the surgical method will be evaluated by this indicator

During hospitalization, common complications of pancreaticoduodenectomy, such as postoperative pancreatic fistula, bile leak, gastrojejunostomy leak, and delayed gastric emptying, will be recorded according to the international diagnostic criteria to evaluate the short-term safety of this surgical approach

The First Affiliated Hospital of University of South China

Neoplasms, Cystic, Mucinous, and Serous

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Gastrointestinal Agents

Pancrelipase

Pancreatin

Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy.

Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy.

Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy.

Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy.

Robotic pancreaticoduodenectomy

Robotic Distal Pancreatectomy

Laparoscopic Distal Pancreatectomy

Hanyu Zhang, M.D.

Menghua Dai, M.D.

MENGHUA Dai, M.D.

Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations.

Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.

Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment.

Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail.

After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery.

Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.

The enrolled candidates will be split into two subgroups(PD group or DP group) based on the location of their neoplasms. Every subgroups will be divided into two parallel groups by the randomization of intervention plan(lap surgery or robotic surgery)

Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms

The rate of frequency of Clavein-Dindo Grade II-IV complication

patients complain of pain after surgery, 0-10, 10 means the greatest pain

The frequency of grade B or C pancreatic fistula

Quality of life after surgery, greater means higher life satisfaction

The amount of treatment expense and certain procedure expense

The rate of death within 90 days after surgery

For DP groups, the rate of spleen being preserved

Peking Union Medical College Hospital

Symptoms and General Pathology

Death

In this group, patients will undergo laparoscopic pancreaticoduodenectomy.

In this group, patients will undergo open pancreaticoduodenectomy.

During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.

During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.

Wei Guo

Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.

RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors

A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors

The patients number with complications / The total number in this group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimally Invasive Pancreatico-duodenectomy	NCT02807701	Pancreaticoduod...	Laparoscopic pa... Open pancreatic...	- 65 Years	Mansoura University
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas	NCT05788029	Periampullary A...	laparoscopic pa... open pancreatic...	18 Years - 75 Years	Tongji Hospital
A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD	NCT05755607	Pancreatic Canc... Common Bile Duc... Periampullary C...	laparoscopic pa... Robot Pancreati...	18 Years -	The First Affiliated Hospital of University of South China
Minimally Invasive Pancreatico-duodenectomy	NCT02807701	Pancreaticoduod...	Laparoscopic pa... Open pancreatic...	- 65 Years	Mansoura University
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas	NCT05788029	Periampullary A...	laparoscopic pa... open pancreatic...	18 Years - 75 Years	Tongji Hospital
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms	NCT05259384	Pancreatic Neop...	Robotic pancrea... Laparoscopic pa... Robotic Distal ... Laparoscopic Di...	18 Years -	Peking Union Medical College Hospital
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms	NCT05259384	Pancreatic Neop...	Robotic pancrea... Laparoscopic pa... Robotic Distal ... Laparoscopic Di...	18 Years -	Peking Union Medical College Hospital
RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors	NCT04037982	Periampullary T... Complication Death Survival	laparoscopic pa... Open pancreatic...	20 Years - 70 Years	Beijing Friendship Hospital
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas	NCT05788029	Periampullary A...	laparoscopic pa... open pancreatic...	18 Years - 75 Years	Tongji Hospital

Spots Global Cancer Trial Database for laparoscopic pancreaticoduodenectomy