The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer.
The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer?
Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO.
Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer.
The primary endpoint is the rate of malignant gastric outlet obstruction.
Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage. These include locally advanced or metastatic cancers of the pancreatic head, distal bile duct, duodenum, or ampulla. cancers.
Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
ECOG 0 or 1
ASA<4
Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of < 3 with radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for soft diet, and 3 for low residue or full diet.
Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of >2. Gastroparesis is defined as having symptoms of MGOO without radiological and/or endoscopic evidence of mechanical obstruction.
Uncorrectable coagulopathy and/or thrombocytopenia
Age < 18 or ≥ 85
Parallel
ERCP alone
Procedure/SurgeryERCP with biliary stenting will be performed alone. ERCP is part of standard of care for biliary drainage. An endoscope is advanced to the small intestines and a metal stent is inserted through the tumor instead of bypassing the tumor to effectively drain the biliary system under x-ray guidance. Management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed
ERCP +ProEUS-GE
Procedure/SurgeryERCP is performed as described above. following the ERCP, the scoped is switched for an echoendoscope which is advanced to the stomach. A stent is then placed between the stomach and the small intestines, creating a connection (ProEUS-GE).
Rate of gastric outlet obstruction (GOO)
Gastric outlet obstruction is defined as GOOSS of \< 2 AND radiological and/or endoscopic confirmation of the presence of GOO either from a gastroduodenal stricture, stent obstruction, or stent migration.
Rate of adverse events
Adverse events are defined and rated according to the ASGE lexicon for endoscopic adverse events.
Quality of life of the participant
Quality of life will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire. The EQ-5D-5L will also be used to obtain Health Related Quality of Life (HRQoL) or health utilities
Nutritional status
Nutritional status will be assessed using the patient-generated subjective global assessment short form (PG-SGA). The PG-SGA scoring scales from 0 to \>9, with a higher score indicating a need for symptom management or nutritional intervention. We will also assess for sarcopenia by incorporating objective quantification of muscle and adipose tissue compartments. These compartments have been shown to have significant prognostic value in patients with pancreatic cancer, including overall survival.
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Jewish General Hospital
Collaborator
Unity Health Toronto
Collaborator
