Periampullary Carcinoma ResectablePDNCT02474914
Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy
A study testing Octreotide in people with Periampullary Carcinoma Resectable, run by Mansoura University at 1 site in Egypt.
Trial summary
pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Periampullary Carcinoma Resectable
- What is being tested?
- Octreotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Apr 2017
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial.
- patients with non dilated pancreatic duct and soft pancreas
Who cannot join
- Age over 70.
- Patients who underwent total or distal pancreatic resection.
- Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours.
- Patients underwent neoadjuvant chemotherapy or radiotherapy.
- PD more than 3mm.
- firm pancreas.
- PJ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Octreotide in the Prevention of Postoperative Complications After Pancreaticodudenectomy in Patients With Soft Pancreas and Non-dilated Pancreatic Duct: A Prospective Randomized Trial"
pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most frequent complications of PD and the major contributor to postoperative morbidity The aim of this study to evaluate the effect of the perioperative octreotide use after PD for prevention of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative complications, mortality and the cost benefit relationship of the use of the perioperative octreotide.
Read the detailed description
This study will be a prospective randomized controlled trial for perioperative use of octreotide in patients after PD for pancreatic and periampullary tumours from May 2014 to April 2017 in Gastroenterology surgical center, Mansoura University, Egypt.
The primary outcome of the study is the effect of perioperative use of octreotide on the rate of development of postoperative pancreatic fistula in patients after PD for pancreatic and periampullary tumours. The secondary outcome is postoperative overall complications, mortality, duration of the hospital length of stay and cost-benefit relationship of perioperative use of octreotide.
Enrolled patients will be randomized to either the octreotide or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner.
- Conditions
- Periampullary Carcinoma Resectable
- Being tested
- Octreotide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Also called sandostatin
Octreotide will be given after PD
PlaceboDrug
Also called Normal saline
Octreotide will NOT be given after PD
| Study group | Role | What they receive |
|---|---|---|
| Octreotide | Active comparator | Enrolled patients will be randomized to either the octreotide (sandostatin ) or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner. Receives: Drug: Octreotide |
| Placebo | Placebo comparator | pancreaticoduodenectomy without octreotide postoperative Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of development of postoperative pancreatic fistula
POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any volume of drained fluid on or after postoperative day (POD) 3 with amylase content greater than 3 times the serum amylase activity . POPF was graded into Grade A, B, and C according to the clinical course
Measured: 30 day
Secondary outcomes (2)
Delayed gastric emptying
Delayed gastric emptying was defined as output from a nasogastric tube of greater than 500 ml per day that persisted beyond 10th POD, the failure to maintain oral intake by 14th POD, or reinsertion of a nasogastric tube. Biliary leak was defined as the presence of bile in the drainage fluid that persists to 4th POD
Measured: 30 days
duration of the hospital length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Periampullary Carcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman El Nakeeb, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474914
- Sponsor's protocol ID
- Octreotide PD
- Acronym
- PD
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lowy AM, Lee JE, Pisters PW, Davidson BS, Fenoglio CJ, Stanford P, Jinnah R, Evans DB. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg. 1997 Nov;226(5):632-41. doi: 10.1097/00000658-199711000-00008.
PubMed 9389397El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
PubMed 23494109Penumadu P, Barreto SG, Goel M, Shrikhande SV. Pancreatoduodenectomy - preventing complications. Indian J Surg Oncol. 2015 Mar;6(1):6-15. doi: 10.1007/s13193-013-0286-z. Epub 2014 Jan 19.
PubMed 25937757Hashimoto D, Chikamoto A, Ohmuraya M, Hirota M, Baba H. Pancreaticodigestive anastomosis and the postoperative management strategies to prevent postoperative pancreatic fistula formation after pancreaticoduodenectomy. Surg Today. 2014 Jul;44(7):1207-13. doi: 10.1007/s00595-013-0662-x. Epub 2013 Jul 11.
PubMed 23842691Fernandez-Cruz L, Jimenez Chavarria E, Taura P, Closa D, Boado MA, Ferrer J. Prospective randomized trial of the effect of octreotide on pancreatic juice output after pancreaticoduodenectomy in relation to histological diagnosis, duct size and leakage. HPB (Oxford). 2013 May;15(5):392-9. doi: 10.1111/j.1477-2574.2012.00608.x. Epub 2012 Nov 19.
PubMed 23557411Yeo CJ, Cameron JL, Lillemoe KD, Sauter PK, Coleman J, Sohn TA, Campbell KA, Choti MA. Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial. Ann Surg. 2000 Sep;232(3):419-29. doi: 10.1097/00000658-200009000-00014.
PubMed 10973392Montorsi M, Zago M, Mosca F, Capussotti L, Zotti E, Ribotta G, Fegiz G, Fissi S, Roviaro G, Peracchia A, et al. Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clinical trial. Surgery. 1995 Jan;117(1):26-31. doi: 10.1016/s0039-6060(05)80225-9.
PubMed 7809832
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Octreotide in the Prevention of Postoperative Complications After Pancreaticodudenectomy in Patients With Soft Pancreas and Non-dilated Pancreatic Duct: A Prospective Randomized Trial"
- ClinicalTrials.gov ID
- NCT02474914
- Acronym / sponsor ID
- PD / Octreotide PD
- Conditions
- Periampullary Carcinoma Resectable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Jun 2015 (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.
pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most frequent complications of PD and the major contributor to postoperative morbidity The aim of this study to evaluate the effect of the perioperative octreotide use after PD for prevention of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative complications, mortality and the cost benefit relationship of the use of the perioperative octreotide.
Detailed description
This study will be a prospective randomized controlled trial for perioperative use of octreotide in patients after PD for pancreatic and periampullary tumours from May 2014 to April 2017 in Gastroenterology surgical center, Mansoura University, Egypt.
The primary outcome of the study is the effect of perioperative use of octreotide on the rate of development of postoperative pancreatic fistula in patients after PD for pancreatic and periampullary tumours. The secondary outcome is postoperative overall complications, mortality, duration of the hospital length of stay and cost-benefit relationship of perioperative use of octreotide.
Enrolled patients will be randomized to either the octreotide or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide | Active comparator | Drug: OctreotideEnrolled patients will be randomized to either the octreotide (sandostatin ) or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner. |
| Placebo | Placebo comparator | Drug: Placebopancreaticoduodenectomy without octreotide postoperative |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial.
- patients with non dilated pancreatic duct and soft pancreas
Key exclusion criteria (7 listed)
- Age over 70.
- Patients who underwent total or distal pancreatic resection.
- Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours.
- Patients underwent neoadjuvant chemotherapy or radiotherapy.
- PD more than 3mm.
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 |
|---|---|---|
| OctreotideAlso: sandostatinOctreotide will be given after PD | Drug | Octreotide |
| PlaceboAlso: Normal salineOctreotide will NOT be given after PD | Drug | Placebo |
Primary outcome
the rate of development of postoperative pancreatic fistula
Time frame: 30 day
POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any volume of drained fluid on or after postoperative day (POD) 3 with amylase content greater than 3 times the serum amylase activity . POPF was graded into Grade A, B, and C according to the clinical course
2 secondary outcomes
Delayed gastric emptying
Time frame: 30 days
duration of the hospital length of stay
Time frame: 30 days
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 22 Aug 2017.
- Background: PubMed 9389397Lowy AM, Lee JE, Pisters PW, Davidson BS, Fenoglio CJ, Stanford P, Jinnah R, Evans DB. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg. 1997 Nov;226(5):632-41. doi: 10.1097/00000658-199711000-00008.
- Results publication: PubMed 23494109El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.
- Results publication: PubMed 25937757Penumadu P, Barreto SG, Goel M, Shrikhande SV. Pancreatoduodenectomy - preventing complications. Indian J Surg Oncol. 2015 Mar;6(1):6-15. doi: 10.1007/s13193-013-0286-z. Epub 2014 Jan 19.
- Results publication: PubMed 23842691Hashimoto D, Chikamoto A, Ohmuraya M, Hirota M, Baba H. Pancreaticodigestive anastomosis and the postoperative management strategies to prevent postoperative pancreatic fistula formation after pancreaticoduodenectomy. Surg Today. 2014 Jul;44(7):1207-13. doi: 10.1007/s00595-013-0662-x. Epub 2013 Jul 11.
- Results publication: PubMed 23557411Fernandez-Cruz L, Jimenez Chavarria E, Taura P, Closa D, Boado MA, Ferrer J. Prospective randomized trial of the effect of octreotide on pancreatic juice output after pancreaticoduodenectomy in relation to histological diagnosis, duct size and leakage. HPB (Oxford). 2013 May;15(5):392-9. doi: 10.1111/j.1477-2574.2012.00608.x. Epub 2012 Nov 19.
- Results publication: PubMed 10973392Yeo CJ, Cameron JL, Lillemoe KD, Sauter PK, Coleman J, Sohn TA, Campbell KA, Choti MA. Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial. Ann Surg. 2000 Sep;232(3):419-29. doi: 10.1097/00000658-200009000-00014.
- Results publication: PubMed 7809832Montorsi M, Zago M, Mosca F, Capussotti L, Zotti E, Ribotta G, Fegiz G, Fissi S, Roviaro G, Peracchia A, et al. Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clinical trial. Surgery. 1995 Jan;117(1):26-31. doi: 10.1016/s0039-6060(05)80225-9.
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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.
Ayman El Nakeeb, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octreotide in people with Periampullary Carcinoma Resectable, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 7 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 22 Aug 2017. 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 Egypt. 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?
the rate of development of postoperative pancreatic fistula (time frame: 30 day). 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 NCT02474914, which also lists 7 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 22 Aug 2017.