EUS-guided Versus Laparoscopic Gastrojejunostomy for Malignant Gastric Outlet Obstruction

NCT05605327 | Unknown DMC FDA Device

• 1 other identifier: s65286
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastric outlet obstruction (GOO) is a common complication of various types of malignancy arising from the pancreas, bile ducts, retroperitoneum and distal stomach. As these tumours grow they may invade or compress the distal stomach or gastric outlet causing patients to develop the classical manifestations of GOO including vomiting, weight loss, electrolyte disturbances loss of quality of life as well as a reduced life expectancy. Until recently these patients were managed using either endoscopic stenting or surgery. Laparoscopic gastrojejunostomy (L-GJ) has been regarded as the golden standard in the management of GOO. However surgery is invasive and may lead to peri-operative complications and longer hospitalization which further greatly impacts on the quality of life of these patients in which survival is already greatly impaired by their oncological problem. Recently it has been shown that a special stent can be utilized to circumvent the tumour obstruction without the need for surgery. This technique utilizes endoscopic ultrasound to connect the stomach to the jejunum at a site distal to the tumour obstruction. This techniques is minimally invasive compared to surgery. In a large retrospective propensity matched study we recently compared endoscopic ultrasound placement of an AXIOS stent to laparoscopic surgery and could show that the EUS-guided approach led to less complications (2.6 vs 26%) and shorter hospital stay compared to surgery.1 Our study and that of other groups, has led the European Society of Gastrointestinal Endoscopy (ESGE) to recommend that EUS-guided gastrojejunostomy (EUS-GJ) can be considered for patients with malignant GOO as an alternative for surgery and endoscopic stenting, acknowledging that further randomized controlled trials comparing the EUS-GJ approach to surgery, are necessary.2 Based on the above clinical need we set out to design a multicentre international trial with the main aim of comparing EUS-guided gastrojejunostomy to laparoscopic gastroenterostomy. The planned study has two components: 1. Randomized study (EATING RCT)- patients that meet the strict inclusion criteria for the (EATING-RCT) will be randomized to either EUS-GJ or L-GJ. 2. Patients in whom inclusion criteria for the RCT are not met, will be invited to participate in the observational arm of the study (EATING-C) comparing EUS-GJ, enteral stenting and surgical gastrojenostomy in a "real world scenario" setting. With this combined design we aim to include all patients with malignant gastric outlet obstruction undergoing treatment. This will be an international multicentre effort, with expert centers in Belgium and other countries in Europe, including UZ Brussel (BE), UCL (BE), Hôpital Erasme (BE), UCL Namur (BE), UZ Gent (BE), Alicante (Spain), Gemelli Rome (Italy), San-Rafaelle Milan (Italy) and G.B. Rossi University Hospital Verona (Italy) as participating centres (total n=11). This envisaged investigator driven study will be performed using an AXIOS stent produced by the company BOSTON SCIENTIFIC. This stent is registered in Europe and CE approved for the drainage of pancreatic fluid collections, the gall bladder and bile ducts. As described above we and other groups have used this product off-label to succesfully perform EUS-guided GJ. High-quality randomized controlled data are however required that will be generated in the proposed EATING RCT study. It is expected that the data, generated by the EATING RCT trial will contribute significantly to resolve the current question regarding the best management of patients with GOO. Ultimately the objective should be to provide high quality affordable care that is minimally invasive to cancer patients with GOO. Such high quality data will also be crucial when applying for registration and CE approval of this product for use in the management of GOO .

Conditions

Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• Procedure related adverse event

  ASGE lexicon

  90 days

Secondary Outcomes (7)

• Time to oral intake

  90 days

• Hospital stay

  90 days

• Technical success

  with time from EUS-GE placement to discharge (up to 1 week)

• Clinical success

  during admission

• Treatment cost

  within 12 months

Study Arms (2)

EUS-guided gastroenterostomy

EXPERIMENTAL

Device: EUS-guided gastroenterostomy

Laparoscopic gastroenterostomy

ACTIVE COMPARATOR

Other: Laparoscopic gastroenterostomy

Interventions

EUS-guided gastroenterostomy DEVICE

EUS-guided gastroenterostomy using the Hot-Axios and the WEST approach.

EUS-guided gastroenterostomy

Laparoscopic gastroenterostomy OTHER

Laparoscopic gastroenterostomy

Laparoscopic gastroenterostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• ≥ 18 years old
• Endoscopic or radiological confirmation of a gastric outlet obstruction due to an obstructive malignant neoplastic lesion extending from the distal one third of the stomach or the duodenum
• GOOSS score(8) \< 2 (no oral intake or liquids only)
• Performance status justifying palliative treatment for mGOO
• No contra-indications to undergo deep conscious sedation or general anesthesia All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.
• Endoscopic and surgical creation of a gastrojejunostomy are deemed both technically feasible by the treating physician.
• Expected survival exceeds 2 months.
• ECOG Performance Status ≤2

You may not qualify if:

• Participants eligible for the EATING-C Trial must not meet any of the following criteria:
• Patients with benign GOO
• Patients who are candidates for curative surgical resection of the primary disease
• Patients whose mGOO is likely to resolve very quickly (within days or weeks) under anti-tumoral treatment (such as lymphoproliferative diseases).
• Participants eligible for the EATING-RCT Trial must not meet any of the following criteria:
• ECOG Performance status \> 2
• Peritoneal carcinomatosis with signs of obstruction on cross-sectional imaging (on either small or large bowel level).
• Grade II and III ascites OR ascites interfering with the EUS-GJ trajectory, complicating successful creation of an EUS-GJ.
• Previous surgical procedures or reconstructions impeding EUS-GJ.
• Diffuse tumor involvement of the gastric wall impeding EUS-GJ
• Participation in other interventional procedures which may be of influence on primary or secondary outcome parameters
• Presence of other strictures in gastrointestinal tract leading to radiological or clinical signs of obstruction or patency issues.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Erasme University Hospital: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• University Hospital, Ghent: collaborator
• Université Catholique de Louvain: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital del Rio Hortega: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Universita di Verona: collaborator

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Michiel Bronswijk, MD

CONTACT

+3215505159; mjh.bronswijk@gmail.com

Natalie Vandenende

CONTACT

natalie.vandenende@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: November 4, 2022
• Study Start: November 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share