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early enteral nutrition with standard enteral formulas administered through a nasojejunal tube

early oral nutrition with hospital diets and oral formulas

Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.

Enteral nutrition

Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated

Oral nutrition

Maciej Słodkowski, MD

Marek Wroński, MD

Marek Wroński, MD,PhD

Marcin Makiewicz, MD

Marek Wronski, MD

Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial.

The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). 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 PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

Background \& aim: Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial. There are not any standard protocols for nutritional support after major upper gastrointestinal surgery in these patients and postoperative nutritional regimens depend mainly upon surgeon's or center preference.

Patients undergoing pancreatoduodenectomy often begin oral intake a week after operation and enteral or parenteral nutrition is used to cover the daily caloric requirements during this period, although their role still remains questionable. The safety of early oral nutrition has been confirmed in the majority of gastrointestinal procedures. However, pancreatic surgeons are quite reluctant to advance oral diet within the first postoperative week after pancreatoduodenectomy due to fear of anastomosis breakdown or delayed gastric emptying syndrome. These two postoperative nutritional regimens, early oral vs. early enteral nutrition, have not been sufficiently evaluated in a prospective, randomized study.

Material and Methods: 96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. The enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

Purpose: The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Medical University of Warsaw

Calculi

Constriction, Pathologic

Hemobilia

Hemorrhage

ERCP procedure will be performed to visualize bile ducts.

ERCP (Endoscopic Retrograde Cholangiopancreatography)

Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed

SpyGlass DVS and SpyGlass Digital Simple (DS)

Benedict Devereaux

James Lau

Randhir Sud

Saad Niaz

Abdulrahman Aljebreen

Ang Tiing Leong

Jorg Reichenberger

Jong Moon

Rungsun Rerknimitr

Ichiro Yasuda

Arthur J. Kaffes

Nam Q. Nguyen

Amit Maydeo

Mohan Ramchandani

Mahesh Goenka

Professor R. Kochhar

Takao Itoi

Masayuki Kitano

Jong K. Lee

Dongwan Seo

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

SpyGlass AMEA Registry

Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region

For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology

For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.

For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.

Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit.

Assessment Detail:

Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported.

Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus.

Boston Scientific Corporation

Endocrine Gland Neoplasms

Endocrine System Diseases

Hepaticojejunostomy and gastroenterostomy

Stent strategy

Lars Fändriks, Professor

Claes Jönsson, Ass. Prof.

Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.

Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study

Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries

The numbers of surgical, radiological or endoscopical interventions due to jaundice or gastric outlet obstruction from date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months"

Göteborg University

Death

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

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.

laparoscopic pancreaticoduodenectomy

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.

Open pancreaticoduodenectomy

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

Beijing Friendship Hospital

Chief Physician

Central Nervous System Depressants

Anti-Infective Agents

Anesthetics

Anti-Bacterial Agents

Somatostatin

Ethanol

Bilirubin

* Preop usual biliary drainage
* Preop smoking and alcohol
* Preop parenteral nutrition
* Oral bowel preparation (mechanical bowel preparation )
* Preoperative fasting \> 12 hours
* Pre-anesthetic medication
* Anti-thrombotic prophylaxis
* Antimicrobial prophylaxis and skin preparation
* Intravenous analgesia : PCA
* Prevention of postoperative nausea and vomiting (PONV) (X)
* Incision : surgeon direction
* Avoiding hypothermia
* Nasogastric intubation (O)
* Postop glycemic control
* Positive fluid balance
* Perianastomotic drain removal over POD #5
* Somatostatin analogues
* Transurethral catheter removal
* Delayed gastric emptying(DGE) (+) , parenteral nutrition (+)
* Postop routine artificial nutrition (O), soft diet at POD #5
* Early and scheduled mobilization

* behavioral intervention (counselling, audit)
* dietary supplement
* procedure (preoperative and postoperative)
* drug

* Preop Counseling
* Preop biliary drainage (X) when Serum Total bilirubin \< 14.62mg/dl and cholangitis (-)
* Preop enteral nutrition
* Oral bowel preparation (mechanical bowel preparation ) (X)
* Preop fasting \< 6 hours
* Prevention of postoperative nausea and vomiting (PONV) (O)
* Nasogastric intubation (X)
* Near-zero fluid balance
* Somatostatin analogues (X)
* Postop routine artificial nutrition (X), soft diet at POD #2
* Audit
* Other items are same as conventional

ERAS perioperative management

Dae Wook Hwang, M.D.

Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

This study investigate the clinical effectiveness of ERAS on PD.

* This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.
* The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.
* Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.
* Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently

Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.

The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.

The Effect of ERAS on Pancreaticoduodenectomy

The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy

At initial status of this study, IRB was approved at limited data access only.

The incidence of operation-related morbidity

The incidence of 30 days mortality and in-hospital mortality

The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2\~3months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy	NCT01642875	Pancreatic Canc... Cancer of the D... Cholangiocarcin... Chronic Pancrea...	Enteral nutriti... Oral nutrition	18 Years -	Medical University of Warsaw
SpyGlass AMEA Registry	NCT02281019	Biliary Strictu... Biliary Obstruc... Periampullary T... Hemobilia	ERCP (Endoscopi... SpyGlass DVS an...	18 Years -	Boston Scientific Corporation
Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer	NCT01569282	Pancreatic Canc... Periampullary T...	Hepaticojejunos... Stent strategy	18 Years - 85 Years	Göteborg University
SpyGlass AMEA Registry	NCT02281019	Biliary Strictu... Biliary Obstruc... Periampullary T... Hemobilia	ERCP (Endoscopi... SpyGlass DVS an...	18 Years -	Boston Scientific Corporation
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
The Effect of ERAS on Pancreaticoduodenectomy	NCT02372331	Periampullary T...	ERAS perioperat...	18 Years - 80 Years	Asan Medical Center

Spots Global Cancer Trial Database for periampullary tumor