Trial Title:
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
NCT ID:
NCT05561907
Condition:
Gastric Outlet Obstruction
Conditions: Official terms:
Gastric Outlet Obstruction
Pyloric Stenosis
Conditions: Keywords:
Gastric outlet obstruction
GOO
Periampullary malignancy
Periampullary cancer
Surgical gastrojejunostomy
Endoscopic gastrojejunostomy
Gastrojejunostomy
Enteral anastamosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Subjects will be randomly assigned in a 1:1 ratio to surgical gastrojejunostomy (SGJ) or
endoscopic gastrojejunostomy (EGJ).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Surgical gastrojejunostomy (SGJ)
Description:
Laparoscopic gastrojejunostomy
Arm group label:
Surgical gastrojejunostomy (SGJ)
Intervention type:
Procedure
Intervention name:
Endoscopic gastrojejunostomy (EGJ)
Description:
Endoscopic ultrasound (EUS) guided gastrojejunostomy
Arm group label:
Endoscopic gastrojejunostomy (EGJ)
Summary:
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
Detailed description:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the
distal duodenum (D3) or distal (antrum) gastric cancer
2. Symptoms of gastric outlet obstruction (at least 2 of 4 required):
1. post prandial vomiting,
2. abdominal pain,
3. inability to tolerate PO,
4. imaging consistent with GOO
3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1
(liquids only)
4. Age >18 years old
5. Life expectancy greater than 2 months or failed duodenal stenting
6. Surgical Candidate/Tolerate General Anesthesia
7. Unresectable or metastatic disease
Exclusion Criteria:
1. Age< 18 years old
2. Pregnancy
3. Intestinal obstruction distal to the Ligament of Treitz
4. Evidence of other luminal strictures of the GI tract
5. Previous gastric or periampullary surgery
6. Inability to complete quality of life surveys (QOLS)
7. Presence of abdominal ascites
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
North Shore University Hospital
Address:
City:
Manhasset
Zip:
11030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Molly Stewart
Phone:
718-470-4667
Email:
mstewart8@northwell.edu
Contact backup:
Last name:
Hye Jeong Jang
Phone:
718-470-7983
Email:
hjang3@northwell.edu
Investigator:
Last name:
Matthew Weiss, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sandeep Anantha, MD
Email:
Sub-Investigator
Investigator:
Last name:
John Wang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Arvind Trindade, MD
Email:
Principal Investigator
Investigator:
Last name:
Petros Benias, MD
Email:
Principal Investigator
Facility:
Name:
Long Island Jewish Medical Center
Address:
City:
New Hyde Park
Zip:
11040
Country:
United States
Status:
Recruiting
Contact:
Last name:
Molly Stewart
Phone:
718-470-4667
Email:
mstewart8@northwell.edu
Contact backup:
Last name:
Hye Jeong Jang
Phone:
718-470-7983
Email:
hjang3@northwell.edu
Investigator:
Last name:
Arvind Trindade, MD
Email:
Principal Investigator
Investigator:
Last name:
Petros Benias, MD
Email:
Principal Investigator
Investigator:
Last name:
Matthew Weiss, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sandeep Anantha, MD
Email:
Sub-Investigator
Investigator:
Last name:
John Wang, MD
Email:
Sub-Investigator
Facility:
Name:
Lenox Hill Hospital
Address:
City:
New York
Zip:
10075
Country:
United States
Status:
Recruiting
Contact:
Last name:
Molly Stewart
Phone:
718-470-4667
Email:
mstewart8@northwell.edu
Contact backup:
Last name:
Hye Jeong Jang
Phone:
718-470-7983
Email:
hjang3@northwell.edu
Investigator:
Last name:
Petros Benias, MD
Email:
Principal Investigator
Start date:
October 28, 2022
Completion date:
June 2025
Lead sponsor:
Agency:
Northwell Health
Agency class:
Other
Source:
Northwell Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05561907
