Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Pancreatic Neoplasms

Cholangiocarcinoma

Duodenal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Bile Duct Neoplasms

Gastrointestinal Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

Pancreatic Cancer

Bile Duct Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Irinotecan

Pancrelipase

Pancreatin

Topoisomerase I Inhibitors

Enzyme Inhibitors

irinotecan

radiation therapy

Syma Iqbal, M.D.

This study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery. Radiation therapy is commonly used in the treatment of these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU). In this study, doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation. The purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy, and to determine the side effects when these two treatments are given together. Irinotecan is approved by the Food and Drug Administration (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive tract. However, the FDA is allowing its use in this research study.

Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

University of Southern California

Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation

pancreaticoduodenectomy

The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone

Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons.

Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial.

In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).

The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason

The proportion of all complications after operation accounted for the total number of patients

The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.

he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.

Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.

Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Symptoms and General Pathology

Jaundice

Jaundice, Obstructive

Head and Neck Neoplasms

Hyperbilirubinemia

Skin Manifestations

biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer

biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer

biliary drainage

Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.

Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice

at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)

Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)

Total hospital cost during admission after Biliary Drainage in US dollars

Seoul National University Hospital

Professor

final biliary drainage procedure: biliary drainage via PTBD

Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting

PTBD

final biliary drainage procedure: biliary drainage via ERBD/ENBD

Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting

ERBD

final biliary drainage procedure: biliary drainage via ERBD/ENBD

final biliary drainage procedure : biliary drainage via PTBD

Total

Age, Continuous

Sex: Female, Male

Korea, Republic of

Region of Enrollment

Sun-Whe Kim

finial biliary drainage procedure: biliary drainage via PTBD

finial biliary drainage procedure: biliary drainage via ERBD or ENBD

Incidence of Infectious Complications After Biliary Drainage

Final biliary drainage procedure: biliary drainage via PTBD

Final biliary drainage procedure: biliary drainage via ENBD/ERBD

ENBD/ERBD

Change in Total Serum Bilirubin After Drainage

Final biliary drainage procedure: biliary drainage via ERBD/ENBD

Total Hospital Cost During Admission After Biliary Drainage

biliary drainage : biliary drainage via ERBD/ENBD

biliary drainage : biliary drainage via PTBD

Overall Study

Gastroparesis

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.

Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.

Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.

Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. Standard enteral diet, administered through a nasojejunal tube, is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.

After PD, enteral nutrition liquid regimen will be used step by step from postoperative day 1 to postoperative day 7.Patients are targeted to receive calories for 25 kcal/kg/day. Meanwhile, oral food intake was not restricted.

Early enteral nutrition

Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament.

After PPPD,Only Normal Saline were given through nasojejunal tube. Entral nutrition was not administrated. Patients intake food orally at will.

Saline

nasojejunal tube insertion

Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.

Oral intake

Yi Miao, Prof.

Junli Wu, MD,PhD

Jishu Wei, MD,PhD

Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition.

Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.

Enteral Nutrition After Pancreaticoduodenectomy

Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.

according to classification of Dindo-Clavien

evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients

evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients

Fasting plasma concentration GLP-1 level was monitored

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers	NCT00183846	Pancreatic Canc... Gastric Cancer Duodenum Cancer Bile Duct Cance...	irinotecan radiation thera...	18 Years -	University of Southern California
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone	NCT04763642	Pancreatic Canc... Bile Duct Cance... Ampulla of Vate...	pancreaticoduod...	21 Years - 80 Years	State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers	NCT01134276	Periampullary C... Pancreas Head C... Bile Duct Cance... Ampulla of Vate...	biliary drainag...	20 Years - 85 Years	Seoul National University Hospital
Enteral Nutrition After Pancreaticoduodenectomy	NCT03150615	Cancer of Pancr... Cancer of Duode... Ampulla of Vate... Cholangiocarcin...	Early enteral n... Saline nasojejunal tub... Oral intake	18 Years - 80 Years	Nanjing Medical University

Spots Global Cancer Trial Database for ampulla of vater cancer