Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

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

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Antidiarrheals

Loperamide

Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach

Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach

Isoperistaltic

Antiperistaltic

Seung Wan Ryu, M.D., Ph.D.

Seung Wan Ryu, MD, PhD

In Gyu Kwon, MD

Young Gil Son, MD, PhD

Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study

Keimyung University Dongsan Medical Center

Director of Gastrointesinal surgery, professor

gastroduodenal stent placement

gastrojejunostomy

Yoomoon Won, MD

Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the patient population. Therefore, to establish the standard of care for patients with radically unresectable gastric cancer with gastric outlet obstruction, a larger prospective, randomized, controlled clinical trial using a single type of stent is warranted.

Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

Asan Medical Center

Professor

Symptoms and General Pathology

Gastric Outlet Obstruction

Pyloric Stenosis

Constriction, Pathologic

An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.

A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.

Surgical gastrojejunostomy (SGJ)

Endoscopic ultrasound (EUS) guided gastrojejunostomy

Endoscopic gastrojejunostomy (EGJ)

Molly Stewart

Hye Jeong Jang

Matthew Weiss, MD

Sandeep Anantha, MD

John Wang, MD

Arvind Trindade, MD

Petros Benias, MD

Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment

After potential subjects are screened from the physicians' schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study.

After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner.

On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status.

Data will be collected during and immediately following the procedure to assess for any possible adverse events.

Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure.

QOL Scoring Systems GOOSS- Gastric Outlet Obstruction Symptom Score

* 1 Inadequate or no oral intake
* 2 Liquids/thickened liquids
* 3 Semisolids/ low residue
* 4 unmodified

GFS- Gut Function Score from Lowe et al 2002

* 0 Profuse vomiting
* 1 Nausea and occasional vomiting
* 2 Nausea only
* 3 Normal gut function

Pre-Procedure Variables to Record Demographic

* Gender
* Weight
* BMI
* Cancer Type

Clinical Parameters

* GOOSS
* Gut Function Score
* Karnofsky Performance Scale

Procedural Parameters

* EUS-GJ: presence of ascites, able to pass scope beyond obstruction, use of wire to stabilize position, Length of procedure, intraprocedural AEs, Stent size used, successful completion of procedure
* Laparoscopic GJ: presence of ascites, length of procedure, intraprocedural AEs, conversion to open GJ, successful completion of procedure

Post-procedure Hospitalization Daily Function

* GOOSS
* Gut Function Score
* Time to initiation of oral intake liquids
* Time to initiation of oral intake solids
* Time to discharge
* Post procedural AEs

  30 Day Outcomes
* GOOSS
* Gut Function Score
* Karnofsky Performance Scale
* Weight/BMI
* Able to tolerate TB approved chemotherapeutic regimen

Subjects will be randomly assigned in a 1:1 ratio to surgical gastrojejunostomy (SGJ) or endoscopic gastrojejunostomy (EGJ).

Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2

All adverse events (AEs) occurring after treatment will be graded according to ASGE lexicon. A subject will be considered to have had an adverse event if they had one or more adverse events, and they will be considered to have had a serious adverse event (SAE) if they had one or more serious adverse events

Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.

Clinical success is defined as improvement to a GOOSS score of 2 or 3 (oral intake of soft solid foods or resumption of full diet) without additional intervention.

Length of stay will be measured from randomization to discharge alive. All patients will be followed until discharge. Patients who die in hospital will be considered censored and time from randomization to death will be used.

BMI will be measured immediately prior to the procedure, and at one month and three months after the procedure.

Albumin levels will be measured immediately prior to the procedure, and at one month and three months after the procedure.

The Gastric Outlet Obstruction Symptom Score (GOOSS) scale is as follows, whereas a score of 1 is the worst and a score of 4 is the best:

1. Inadequate or no oral intake
2. Liquids/thickened liquids
3. Semisolids/ low residue
4. Unmodified

GOOSS will be recorded at each of the following timepoints:

* immediately prior to the procedure
* immediately post-procedure
* 1-day post-procedure
* 2-days post-procedure
* 3-days post-procedure
* 4-days post-procedure
* 7-days post-procedure,
* 30-days post-procedure
* 3-months post-procedure
* 6-months post-procedure
* 1-year post-procedure

Gut Function Score (GFS) scale is as follows, whereas a score of 1 is the worst and a score of 3 is the best:

0. Profuse vomiting

1. Nausea and occasional vomiting
2. Nausea only
3. Normal gut function

GFS will be recorded at each of the following timepoints:

* Immediately prior to the procedure
* Immediately post-procedure
* 1-day post-procedure
* 2-days post-procedure
* 3-days post-procedure
* 4-days post-procedure
* 7-days post-procedure,
* 30-days post-procedure
* 3-months post-procedure
* 6-months post-procedure
* 1-year post-procedure

Karnofsky Performance Scale is measured on a scale of 0 to 100 as follows, with a score of 0 being the worst and a score of 100 being the best:

100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs.

50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.

20 - Very sick; hospital admission necessary; active supportive treatment necessary.

10 - Moribund; fatal processes progressing rapidly. 0 - Dead

KPS will be recorded pre-procedure and at 30-days post-procedure.

Ability to tolerate TB approved chemotherapeutic regimen

Northwell Health

Director of Endoscopic Surgery

Endoscopic placement of enteral Self-Expandable Metal Stents (SEMS). The procedure implies endoscopic identification of the stricture, placement of a guidewire through the stricture and placement of a SEMS through the stricture under fluoroscopic control.

The procedure implies distention of the jejunal loop and EUS-guided placement of an electrocautery-enhanced (EC) LAMS connecting the stomach to a jejunal loop distal to the stenosis. Any technique for EUS-GE will be allowed, provided that an EC-LAMS \>15mm will be used.

The procedure implies a surgical anastomosis between gastric wall and a jejunal loop. The procedure can be performed either through laparoscopy or open surgery.

Giuseppe Vanella, MD

Laura Apadula

Charles De Ponthaud

Sebastien Gaujoux

Giacomo Rizzo

Filipe Vilas Boas Silva

Bahadir Bozkırlı

Gabriele Capurso, MD

The aim of this observational study is to compare the outcomes of three different procedures performed for the management of malignant Gastric Outlet Obstruction due to Pancreatic Cancer.

Patients who undergo:

* Surgical gastroenterostomy
* Endoscopic placement of a self-expanding metallic stent
* EUS-guided gastroenterostomy in accordance with standard clinical practice, will be enrolled to evaluate potential differences between the procedures in terms of clinical success, eating experience, chemotherapy tolerance, and nutritional status during follow-up.

Participants will be asked to complete a quality of life questionnaire at baseline and during follow-up; however, no additional procedures will be conducted as a result of participation in the study.

Gastric Outlet Obstruction (GOO) syndrome is a frequent complication of biliopancreatic and gastroduodenal neoplasms and manifests with recurrent vomiting, dehydration and malnutrition, seriously compromising quality of life and the ability to tolerate chemotherapy.

Standard treatment options for GOO are surgical gastroenterostomy (S-GE) or endoscopic placement of a self-expanding metallic stent (ES): surgical treatment achieves better long-term results at the cost of a more invasive procedure. The advances of therapeutic endosonography (EUS) have provided a new possibility to resolve this condition through EUS-guided gastroenterostomy (EUS-GE). The latter involves the creation of a gastroenteric bypass by endoscopically positioning a lumen-apposing metal stent (LAMS). Recent evidence has shown several advantages over previous treatments, in terms of less invasiveness compared to surgery and greater long-term efficacy compared to enteral stenting. However, most of the evidence comes from retrospective protocols and heterogeneous studies that include different neoplasms and clinical courses. Furthermore, the definition of clinical success in the current literature refers to the resolution of the mechanical obstruction of the syndrome, without any in-depth study on the clinical impact of different management strategies in terms of more complex outcomes, such as survival, quality of life, nutritional status and chemotherapy tolerance.

The aim of this study is to prospectively analyze the long-term clinical impact of GOO management strategies in a homogeneous cohort of patients with pancreatic adenocarcinoma (PC) and recent disease diagnosis.

The design of this study is:

* Observational
* Prospective
* Multicentric
* Comparative (3-arms)

No changes to the current clinical practice of the participating centers are foreseen. Each center will candidate the enrolled patient to the procedure that is routinely and currently used in that clinical scenario at their own center. Enrollment in the protocol does not require additional investigations or treatments, except for the administration of quality-of-life questionnaires. Participation in the study implies sharing of information standardly collected during the oncological journey. The prospective follow-up will address clinical efficacy, safety and patient-reported experience, including assessment of the eating experience, chemotherapy tolerance and nutritional status.

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

GOOSS \>/= 3, that is the possibility to eat a full diet

Any post-procedural undesirable event requiring an escalation of medical care (additional investigations or treatments, including medical therapy)

Persistent recurrence of obstructing symptoms (GOOS Score \</=1) after a former clinical success (GOOS Score \>/=2)

A Gastric Outlet Obstruction Scoring System (GOOSS) \>/= 2 after the initial intervention, corresponding to the ability to eat at least soft solids

Mean difference in the Anorexia Cachexia subscale of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale between pre- and post-procedure

Delay or discontinuation of an intended chemotherapy regimen

A numerical value calculated by dividing a person's weight in kilograms by the square of their height in meters

Muscle area calculated using CT scans using dedicated software

Evaluated through the Prognostic Nutritional Index, using biochemical values stardardly evaluated during chemotherapy

European Pancreatic Club

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

IRCCS San Raffaele

Principal Investigator

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Amino Acids

Dacomitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients with locally advanced head and neck squamous cell carcinoma will be treated with a single dose (45mg) of PF-00299804 via G-Tube on an empty stomach

Tablet, single dose of 45 mg via gastrojejunostomy tube (G-Tube) on an empty stomach

PF-00299804

Lillian Siu, MD

This is a study to assess how much of the investigational drug, PF-00298804, is in the blood stream over a period of time (called pharmacokinetic tests or PK) in patients with locally advanced head and neck squamous cell carcinoma who have a (gastrojejunostomy) feeding tube.

This is a single arm pharmacokinetic assessment study conducted at Princess Margaret Hospital in which eligible patients will be enrolled successively to receive a single dose of PF-00299804 in an open-labelled, unblinded manner. All patients will receive 45 mg of PF-00299804 via Gastrostomy (GT) once only on an empty stomach (i.e. 2 hours before or after oral food intake or GT feeds (food intake of less than 500 calories permitted)) as an inpatient. All patients will be admitted for an overnight inpatient stay (approximately 24 hours) to facilitate pharmacokinetic assessment. There will be no dose reductions or modifications. Blood sampling for pharmacokinetics will occur on day 1 immediately prior to the dose of PF-00299804 (t=0), then at t=30 minutes, t=1 hour, t=2 hours, t=3 hours, t=4 hours, t=6 hours, t=12 hours, t=24 hours, t=48 hours, t=72 hours, t=96 hours, t=144 hours, t=168 hours, t=192 hours, and t=216 hours.

A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma

Pharmacokinetic Assessment of PF-00299804 in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Following Administration Through a Gastrojejunostomy Feeding Tube

Tmax=4-24 hrs, Cmax = 28.1 ng/ml, AUCtau=47 hr\*ng/ml, t1/2=85.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer	NCT01569282	Pancreatic Canc... Periampullary T...	Hepaticojejunos... Stent strategy	18 Years - 85 Years	Göteborg University
Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy	NCT02837874	Stomach Neoplas...	Isoperistaltic Antiperistaltic	20 Years - 80 Years	Keimyung University Dongsan Medical Center
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy	NCT02784470	Gastric Cancer	gastroduodenal ... gastrojejunosto...	19 Years - 80 Years	Asan Medical Center
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy	NCT05561907	Gastric Outlet ...	Surgical gastro... Endoscopic gast...	18 Years -	Northwell Health
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy	NCT02784470	Gastric Cancer	gastroduodenal ... gastrojejunosto...	19 Years - 80 Years	Asan Medical Center
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy	NCT06071507	Gastric Outlet ... Pancreatic Canc...		18 Years -	IRCCS San Raffaele
A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma	NCT01484847	Head and Neck S...	PF-00299804	18 Years -	University Health Network, Toronto
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy	NCT02784470	Gastric Cancer	gastroduodenal ... gastrojejunosto...	19 Years - 80 Years	Asan Medical Center

Spots Global Cancer Trial Database for gastrojejunostomy