Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
cyto-/histo-logically confirmed pancreatic cancer
a maximum of 6 months from pancreatic cancer diagnosis and candidate to active treatment
stenosis causing gastric outlet obstruction (GOO) due to neoplastic invasion/compression confirmed by radiology or endoscopy extending from the distal one third of the stomach or the duodenum
patients candidate to either ES or EUS-GE or s-GE
Disqualifiers
age < 18 years
patients with benign or indeterminate gastrointestinal stenosis
patients with malignant GOO (mGOO) from neoplasia other than pancreatic cancer
candidates to upfront surgical resection or who already received curative pancreatic resection
Trial population
A homogeneous population of patients with pathologically confirmed Pancreatic Cancer, candidate to palliation of Gastric Outlet Obstruction and active oncological treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 3 trial groupsGroup A: Enteral Stenting
Group B: EUS-guided Gastrojejunostomy
Group C: Surgical Gastrojejunostomy
Trial outcomes
Primary outcomes
1
Clinical Success
A Gastric Outlet Obstruction Scoring System (GOOSS) \>/= 2 after the initial intervention, corresponding to the ability to eat at least soft solids
Time frame
30 daysSecondary outcomes
1
Eating Experience
Mean difference in the Anorexia Cachexia subscale of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale between pre- and post-procedure
Time frame
3 months2
Chemotherapy Tolerance
Delay or discontinuation of an intended chemotherapy regimen
Time frame
24 months3
Body Mass Index
A numerical value calculated by dividing a person's weight in kilograms by the square of their height in meters
Time frame
6 months4
Body Composition
Muscle area calculated using CT scans using dedicated software
Time frame
6 monthsOther outcomes
1
Technical Success
completion of the intended procedure
Time frame
Day 02
Full diet
GOOSS \>/= 3, that is the possibility to eat a full diet
Time frame
3 months3
Adverse events
Any post-procedural undesirable event requiring an escalation of medical care (additional investigations or treatments, including medical therapy)
Time frame
30 days4
Symptoms recurrence
Persistent recurrence of obstructing symptoms (GOOS Score \</=1) after a former clinical success (GOOS Score \>/=2)
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Raffaele
Lead sponsor
European Pancreatic Club
Collaborator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Collaborator
Source ClinicalTrials.gov