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CompletedNCT02381249Updated Nov 27, 2023

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

An interventional study of Octreotide and Placebo in Esophageal Neoplasms, Stomach Neoplasms and Weight Loss, sponsored by St. James's Hospital, Ireland. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by St. James's Hospital, Ireland · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery.

In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.

02

Conditions studied

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Weight Loss
  • Malnutrition
  • Pancreatic Neoplasms
  • Duodenal Neoplasms

Keywords

  • Esophagectomy
  • Gastrectomy
  • Octreotide
  • Somatostatin
  • Appetite
  • Hunger
  • Glucagon-Like Peptide 1
  • Peptide YY
  • Reinforcement
  • Reward
  • Psychological Phenomena and Processes
  • Gastrointestinal Agents
  • Nutritional Status
  • Pancreaticoduodenectomy
  • Whipple Procedure
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

St. James's Hospital, Ireland is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Esophagectomy

    Double-blind single dose octreotide-placebo crossover

    Drug: Octreotide · Drug: Placebo

  • Experimental
    Gastrectomy

    Double-blind single dose octreotide-placebo crossover

    Drug: Octreotide · Drug: Placebo

  • Active comparator
    Unoperated healthy control

    Double-blind single dose octreotide-placebo crossover

    Drug: Octreotide · Drug: Placebo

  • Experimental
    Pancreaticoduodenectomy

    Double-blind single dose octreotide-placebo crossover

    Drug: Octreotide · Drug: Placebo

Interventions

  • DrugOctreotide

    Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

    Also known as: Sandostatin

  • DrugPlacebo

    Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

06

What researchers measure

Primary outcomes

  1. Progressive ratio task breakpoint for a sweet-fat reward

    Time frame: 3 hours

Secondary outcomes

  1. Number of rewards consumed

    Time frame: 3 hours

  2. Subjective symptom score

    Time frame: 3 hours

Other outcomes

  1. Sigstad score

    Both categorical and continuous

    Time frame: 3 hours

07

Study locations

2 sites
  • Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
    Dublin, D8, Ireland
  • Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
    Gothenburg, Sweden
08

References and documents

Publications

  • Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25. PubMed 22836034 ↗
  • HODOS W. Progressive ratio as a measure of reward strength. Science. 1961 Sep 29;134(3483):943-4. doi: 10.1126/science.134.3483.943. PubMed 13714876 ↗
  • Miholic J, Orskov C, Holst JJ, Kotzerke J, Pichlmayr R. Postprandial release of glucagon-like peptide-1, pancreatic glucagon, and insulin after esophageal resection. Digestion. 1993;54(2):73-8. doi: 10.1159/000201016. PubMed 8319842 ↗
  • Haverkort EB, Binnekade JM, Busch OR, van Berge Henegouwen MI, de Haan RJ, Gouma DJ. Presence and persistence of nutrition-related symptoms during the first year following esophagectomy with gastric tube reconstruction in clinically disease-free patients. World J Surg. 2010 Dec;34(12):2844-52. doi: 10.1007/s00268-010-0786-8. PubMed 20842361 ↗
  • Koizumi M, Hosoya Y, Dezaki K, Yada T, Hosoda H, Kangawa K, Nagai H, Lefor AT, Sata N, Yasuda Y. Postoperative weight loss does not resolve after esophagectomy despite normal serum ghrelin levels. Ann Thorac Surg. 2011 Apr;91(4):1032-7. doi: 10.1016/j.athoracsur.2010.11.072. PubMed 21440118 ↗
  • le Roux CW, Aylwin SJ, Batterham RL, Borg CM, Coyle F, Prasad V, Shurey S, Ghatei MA, Patel AG, Bloom SR. Gut hormone profiles following bariatric surgery favor an anorectic state, facilitate weight loss, and improve metabolic parameters. Ann Surg. 2006 Jan;243(1):108-14. doi: 10.1097/01.sla.0000183349.16877.84. PubMed 16371744 ↗
  • Elliott JA, Docherty NG, Haag J, Eckhardt HG, Ravi N, Reynolds JV, le Roux CW. Attenuation of satiety gut hormones increases appetitive behavior after curative esophagectomy for esophageal cancer. Am J Clin Nutr. 2019 Feb 1;109(2):335-344. doi: 10.1093/ajcn/nqy324. PubMed 30722001 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02381249
Lead sponsor
St. James's Hospital, Ireland
Collaborators
University College Dublin, University of Dublin, Trinity College, Göteborg University
Responsible party
Dr Jessie A Elliott (Surgical Research Fellow, St. James's Hospital, Ireland) — Principal investigator
First posted
Mar 6, 2015
Start date
Mar 2015
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Nov 27, 2023

Study contacts

John V Reynolds, MCh, FRCS
principal investigator · Department of Surgery, St. James's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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