Digestive System Diseases

All Conditions

Symptoms and General Pathology

Gastric Outlet Obstruction

Pyloric Stenosis

Constriction, Pathologic

Stomach Diseases

Gastrointestinal Diseases

In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.

In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.

Lumen-apposing metal stent

Self-expandable metal stent

Mouen A. Khashab, MD

Lauren A Sekela, MPH

Thiruvengadam Muniraj

Mouen A Khashab, MD

Chris Thompson

Michele Ryan

Gregory Haber

Kavel Visrodia

Todd Baron

Rishi Pawa

Yen-I Chen

Carlos Robles Medranda

Jeremie Jacques

Constance Grunewald

Gianfranco Donatelli

Sundeep Lakhtakia

Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions.

Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.

Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)

EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial

Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.

Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.

The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.

The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.

Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format:

0 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet

the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture

Calculated from the time of stent placement to the time of stent dysfunction

Boston Scientific Corporation

Johns Hopkins University

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction	NCT03259763	Gastric Outlet ...	Lumen-apposing ... Self-expandable...	18 Years - 80 Years	Johns Hopkins University
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy	NCT06071507	Gastric Outlet ... Pancreatic Canc...		18 Years -	IRCCS San Raffaele
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction	NCT03259763	Gastric Outlet ...	Lumen-apposing ... Self-expandable...	18 Years - 80 Years	Johns Hopkins University

Spots Global Cancer Trial Database for gastroenterostomy