Pancreatic FistulaNCT01400100
Effects of Intraarterial Octreotide on Pancreatic Texture
A study testing Intraarterial application of Octreotide and sterile NaCl (sodium chloride) 0,9% solution in people with Pancreatic Fistula, run by St. Josef Hospital Bochum at 1 site in Germany.
Trial summary
The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Intraarterial application of Octreotide and sterile NaCl (sodium chloride) 0,9% solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 an 90 years
- planned pancreatoduodenectomy
- signed informed consent
- pancreatic hardness equal or less than 40 SU as measured by durometer
- normal vascular anatomy of the hepato-pancreatic region
Who cannot join
- planned distal pancreatic resection
- planned non-resectional pancreatic surgery
- acute pancreatitis at the time of surgery
- pancreatic hardness before intervention higher than 40 SU as measured by durometer
- intraoperatively unstable patient
- intraoperative complications
Show all 9Show fewer
- allergy towards octreotide
- anatomical variation of the vascular supply of the liver or pancreas posing an increased risk for octreotide distribution in other organs than pancreas
- lacking gastroduodenal artery or technically impossible cannulation of the artery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
Official title: Changes in Pancreatic Texture After Single-shot Administration of 500 µg Octreotide in the Gastroduodenal Artery During Pancreatoduodenectomy - a Double-Blinded Randomized Controlled Trial
The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant.
A primary end-point of the study is a change in pancreatic texture.
A secondary end-point is the rate of postoperative pancreatic fistula.
Read the detailed description
Soft pancreas is an established risk factor for the development of postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy. Octreotide is believed to harden the pancreas. This theory is based on the results of a single animal experiment and a small case series in humans. This hardening effect of octreotide has not quantitatively been proven in humans and its mechanism is not clear. Histomorphologic correlates of pancreatic hardness are unknown.
In this study all patients who are eligible for pancreatoduodenectomy and sign the informed consent for participation in the study will be recruited. Those of them who prove to have a soft pancreas intraoperatively will receive a single bolus of 500 µg Octreotide in the gastroduodenal artery after its proximal division. Pancreatic hardness in the region of the resection margin will be quantitatively assessed by a Shore durometer before the intervention and at several time-points after it. The suture-holding capacity of pancreatic tissue at the resection margin will be quantitatively assessed by a dynamometer. Histomorphological features of pancreatic tissue will be characterized in details at the Institute of Pathology in order to define possible correlates of pancreatic hardness.
- Conditions
- Pancreatic Fistula
- Being tested
- Intraarterial application of Octreotide, sterile NaCl (sodium chloride) 0,9% solution
- Keywords
- octreotide, intraarterial, pancreatic hardness, pancreatoduodenectomy, durometer, dynamometer
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarterial application of OctreotideDrug
Also called Sandostatin (Novartis Pharma, Switzerland), Bendatreotid, Octreo, Siroctid
500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.
sterile NaCl (sodium chloride) 0,9% solutionDrug
Also called Sodium chloride 0,9% solution
a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery
| Study group | Role | What they receive |
|---|---|---|
| Octreotide | Experimental | Study patients receive after randomization a single shot of 5 mL 500 µg Octreotide in the gastroduodenal artery at the time of its transection. Receives: Drug: Intraarterial application of Octreotide |
| Control | Placebo comparator | Control patients receive after randomization a single shot of 5 mL 0,9% NaCL solution in the gastroduodenal artery at the time of its transection. Receives: Drug: sterile NaCl (sodium chloride) 0,9% solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic hardness
Pancreatic hardness is a quantifiable parameter, measured by a Shore Durometer in Shore Units on a 0-100 SU scale.
Measured: 3 months postoperatively
Secondary outcomes (1)
Rate of postoperative pancreatic fistula
Postoperative pancreatic fistula occurrs after pancreatoduodenectomy with an estimated rate of 5-30% depending on the definition used and a number of factors such as surgical technique, pancreatic texture, experience of the surgeon, hospital volume etc.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Josef Hospital Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlin Belyaev, St. Josef Hospital Bochum
- Investigators
- Orlin Belyaev, MD, Study director, Department of Surgery, St. Josef HospitalChristian Polle, Principal investigator, Ruhr University of BochumWaldemar Uhl, MD, PhD, Study chair, Department of Surgery, St. Josef Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400100
- Sponsor's protocol ID
- 4033-11
- Status last verified
- Mar 2012
- First submitted
- 7 Jul 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foitzik T, Gock M, Schramm C, Prall F, Klar E. Octreotide hardens the pancreas. Langenbecks Arch Surg. 2006 Apr;391(2):108-12. doi: 10.1007/s00423-006-0030-z. Epub 2006 Mar 28.
PubMed 16568326Konstadoulakis MM, Filippakis GM, Lagoudianakis E, Antonakis PT, Dervenis C, Bramis J. Intra-arterial bolus octreotide administration during Whipple procedure in patients with fragile pancreas: a novel technique for safer pancreaticojejunostomy. J Surg Oncol. 2005 Mar 15;89(4):268-72. doi: 10.1002/jso.20193.
PubMed 15726611Belyaev O, Herden H, Meier JJ, Muller CA, Seelig MH, Herzog T, Tannapfel A, Schmidt WE, Uhl W. Assessment of pancreatic hardness-surgeon versus durometer. J Surg Res. 2010 Jan;158(1):53-60. doi: 10.1016/j.jss.2008.08.022.
PubMed 19394646Belyaev O, Polle C, Herzog T, Munding J, Chromik AM, Meurer K, Tannapfel A, Bergmann U, Muller CA, Uhl W. Effects of intra-arterial octreotide on pancreatic texture: a randomized controlled trial. Scand J Surg. 2013;102(3):164-70. doi: 10.1177/1457496913490457.
PubMed 23963030
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pancreatic Texture After Single-shot Administration of 500 µg Octreotide in the Gastroduodenal Artery During Pancreatoduodenectomy - a Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01400100
- Acronym / sponsor ID
- 4033-11
- Conditions
- Pancreatic Fistula
- Keywords
- octreotide, intraarterial, pancreatic hardness, pancreatoduodenectomy, durometer, dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Josef Hospital BochumUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant.
A primary end-point of the study is a change in pancreatic texture.
A secondary end-point is the rate of postoperative pancreatic fistula.
Detailed description
Soft pancreas is an established risk factor for the development of postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy. Octreotide is believed to harden the pancreas. This theory is based on the results of a single animal experiment and a small case series in humans. This hardening effect of octreotide has not quantitatively been proven in humans and its mechanism is not clear. Histomorphologic correlates of pancreatic hardness are unknown.
In this study all patients who are eligible for pancreatoduodenectomy and sign the informed consent for participation in the study will be recruited. Those of them who prove to have a soft pancreas intraoperatively will receive a single bolus of 500 µg Octreotide in the gastroduodenal artery after its proximal division. Pancreatic hardness in the region of the resection margin will be quantitatively assessed by a Shore durometer before the intervention and at several time-points after it. The suture-holding capacity of pancreatic tissue at the resection margin will be quantitatively assessed by a dynamometer. Histomorphological features of pancreatic tissue will be characterized in details at the Institute of Pathology in order to define possible correlates of pancreatic hardness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide | Experimental | Drug: Intraarterial application of OctreotideStudy patients receive after randomization a single shot of 5 mL 500 µg Octreotide in the gastroduodenal artery at the time of its transection. |
| Control | Placebo comparator | Drug: sterile NaCl (sodium chloride) 0,9% solutionControl patients receive after randomization a single shot of 5 mL 0,9% NaCL solution in the gastroduodenal artery at the time of its transection. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 an 90 years
- planned pancreatoduodenectomy
- signed informed consent
- pancreatic hardness equal or less than 40 SU as measured by durometer
- normal vascular anatomy of the hepato-pancreatic region
Key exclusion criteria (9 listed)
- planned distal pancreatic resection
- planned non-resectional pancreatic surgery
- acute pancreatitis at the time of surgery
- pancreatic hardness before intervention higher than 40 SU as measured by durometer
- intraoperatively unstable patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraarterial application of OctreotideAlso: Sandostatin (Novartis Pharma, Switzerland), Bendatreotid, Octreo, Siroctid500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively. | Drug | Octreotide |
| sterile NaCl (sodium chloride) 0,9% solutionAlso: Sodium chloride 0,9% solutiona single intraarterial shot of 5 ml saline solution in the gastroduodenal artery | Drug | Control |
Primary outcome
Pancreatic hardness
Time frame: 3 months postoperatively
Pancreatic hardness is a quantifiable parameter, measured by a Shore Durometer in Shore Units on a 0-100 SU scale.
1 secondary outcome
Rate of postoperative pancreatic fistula
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Background: PubMed 16568326Foitzik T, Gock M, Schramm C, Prall F, Klar E. Octreotide hardens the pancreas. Langenbecks Arch Surg. 2006 Apr;391(2):108-12. doi: 10.1007/s00423-006-0030-z. Epub 2006 Mar 28.
- Background: PubMed 15726611Konstadoulakis MM, Filippakis GM, Lagoudianakis E, Antonakis PT, Dervenis C, Bramis J. Intra-arterial bolus octreotide administration during Whipple procedure in patients with fragile pancreas: a novel technique for safer pancreaticojejunostomy. J Surg Oncol. 2005 Mar 15;89(4):268-72. doi: 10.1002/jso.20193.
- Background: PubMed 19394646Belyaev O, Herden H, Meier JJ, Muller CA, Seelig MH, Herzog T, Tannapfel A, Schmidt WE, Uhl W. Assessment of pancreatic hardness-surgeon versus durometer. J Surg Res. 2010 Jan;158(1):53-60. doi: 10.1016/j.jss.2008.08.022.
- Derived from this study: PubMed 23963030Belyaev O, Polle C, Herzog T, Munding J, Chromik AM, Meurer K, Tannapfel A, Bergmann U, Muller CA, Uhl W. Effects of intra-arterial octreotide on pancreatic texture: a randomized controlled trial. Scand J Surg. 2013;102(3):164-70. doi: 10.1177/1457496913490457.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlin Belyaev, MD study director
Department of Surgery, St. Josef Hospital
Christian Polle principal investigator
Ruhr University of Bochum
Waldemar Uhl, MD, PhD study chair
Department of Surgery, St. Josef Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraarterial application of Octreotide and sterile NaCl (sodium chloride) 0,9% solution in people with Pancreatic Fistula, run by St. Josef Hospital Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic hardness (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400100, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.