The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT02381249
• Date of registration: 02/03/2015
• Prospective Registration: No
• Primary sponsor: St. James's Hospital, Ireland
• Public title: The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
• Scientific title: The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
• Date of first enrolment: March 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02381249
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ireland, Sweden

Contacts

• Name: John V Reynolds, MCh, FRCS
• Affiliation: Department of Surgery, St. James's Hospital

Key inclusion & exclusion criteria

Inclusion criteria:

1. Surgical procedure: Two-stage, three-stage or transhiatal esophagectomy with gastric
conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y
reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control
subjects

2. Disease-free at least one year post-resection

Exclusion criteria:

1. Pregnancy, breastfeeding

2. Significant and persistent chemoradiotherapy and/or surgical complication

3. Other previous upper gastrointestinal surgery

4. Unwell or unable to eat

5. Other disease or medications which may affect satiety gut hormone responses

6. Active and significant psychiatric illness including substance misuse

7. Cognitive or communication issues or any factors affecting capacity to consent to
participation

8. History of significant food allergy, certain dietary restrictions

9. Confirmed or suspected residual or recurrent disease after surgery, second primary
malignancy

10. Requiring adjuvant chemotherapy

11. Contraindication to octreotide administration

12. History of eating disorder



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stomach Neoplasms

Duodenal Neoplasms

Pancreatic Neoplasms

Esophageal Neoplasms

Malnutrition

Weight Loss

Intervention(s)

Drug: Placebo

Drug: Octreotide

Primary Outcome(s)

Progressive ratio task breakpoint for a sweet-fat reward [Time Frame: 3 hours]

Secondary Outcome(s)

Subjective symptom score [Time Frame: 3 hours]

Number of rewards consumed [Time Frame: 3 hours]

Secondary ID(s)

CRFSJ 0057

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University College Dublin

Göteborg University

University of Dublin, Trinity College