Octreotide VS Placebo in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery
Prospective Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy of Octreotide in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation for head and neck (H\&N) cancers. The "blame"of prior chemoradiation tissue damage encouraged compensatory surgical techniques that focused on the insertion of non-irradiated tissue into the field. This study emphasizes a paradigm shift in the understanding and treatment of pharyngocutaneous fistulae. The detrimental effects of salivary enzymes on tissue healing and surgical anastomoses are addressed and novel treatment strategy is outlined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 12, 2019
September 1, 2016
5.7 years
April 29, 2015
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
elimination of post-radiation salivary fistulae
yes/no fistulae formation
up to 7 days after the surgery
Secondary Outcomes (2)
saliva secretion rate
up 14 days after the surgery
pain evaluation
up to 14 days after the surgery
Study Arms (2)
octreotide treatment
EXPERIMENTALThe studied drug Octreotide 100 mcg will be administered I.V in the evening prior to surgery and for two weeks on a thrice daily basis.
placebo treatment
PLACEBO COMPARATORplasebo will be administrated I.V in the evening prior to surgery and two weeks on a thrice daily basis
Interventions
Octreotide has been in clinical use for thirty years and approved for use in Israel in acromegaly and functional gastroenteropancreatic tumours. It is currently being used extensively in surgical patients to prevent pancreatic fistulae1, and in lymphorrhea (both lymphatic malformations and leaks from the thoracic duct)
placebo ( saline) act as comperator in this study.
Eligibility Criteria
You may qualify if:
- Chemoradiation
- Total laryngectomy
- Composite resections for oral/pharyngeal/laryngeal malignant tumors
You may not qualify if:
- Pregnancy
- Patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
- Patients with uncontrolled diabetes mellitus or a fasting plasma glucose \> 250mg/d
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HadassahMO
Jerusalem, Israel
Related Publications (6)
Gilbert MR, Sturm JJ, Gooding WE, Johnson JT, Kim S. Pectoralis major myofascial onlay and myocutaneous flaps and pharyngocutaneous fistula in salvage laryngectomy. Laryngoscope. 2014 Dec;124(12):2680-6. doi: 10.1002/lary.24796. Epub 2014 Jul 30.
PMID: 25132580BACKGROUNDAgra IM, Carvalho AL, Pontes E, Campos OD, Ulbrich FS, Magrin J, Kowalski LP. Postoperative complications after en bloc salvage surgery for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2003 Dec;129(12):1317-21. doi: 10.1001/archotol.129.12.1317.
PMID: 14676158BACKGROUNDBomeli SR, Desai SC, Johnson JT, Walvekar RR. Management of salivary flow in head and neck cancer patients--a systematic review. Oral Oncol. 2008 Nov;44(11):1000-8. doi: 10.1016/j.oraloncology.2008.02.007. Epub 2008 May 16.
PMID: 18486528BACKGROUNDLoguercio C, de Sio I, Romano M, del Vecchio Blanco C, Coltorti M. Effect of somatostatin on salivary secretion in man. Digestion. 1987;36(2):91-5. doi: 10.1159/000199405.
PMID: 2436964BACKGROUNDSpinell C, Ricci E, Berti P, Miccoli P. Postoperative salivary fistula: therapeutic action of octreotide. Surgery. 1995 Jan;117(1):117-8. doi: 10.1016/s0039-6060(05)80242-9. No abstract available.
PMID: 7809829BACKGROUNDVictora CG, Huttly SR, Fuchs SC, Olinto MT. The role of conceptual frameworks in epidemiological analysis: a hierarchical approach. Int J Epidemiol. 1997 Feb;26(1):224-7. doi: 10.1093/ije/26.1.224.
PMID: 9126524BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jeffrey weinberger, MD
hadassah MO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 8, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
September 12, 2019
Record last verified: 2016-09