- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920567
Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion
Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion and Pancreatic Fistula After Pancreatoduodenectomy
This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.
Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.
Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.
Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kwang Yeol Paik, MD, Phd
- Email: kpaik@catholic.ac.kr
Study Contact Backup
- Name: Dong Do You, MD, PhD
- Phone Number: 82312498303
- Email: tzanggu@catholic.ac.kr
Study Locations
-
-
-
Suwon, Korea, Republic of, 16247
- Recruiting
- The Catholic University Of Korea St. Vincent's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who will undergo pancreatoduodenectomy for periampullary tumors
Exclusion Criteria:
- Patients with preoperative pancreatitis
- Patients who did not undergo pancreatoduodenectomy
- Patients who underwent bypass surgery or total pancreatectomy
- Patients who injection of octreotide less than 5 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: octreotide
After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
|
After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
Other Names:
|
Placebo Comparator: Placebo
After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days
|
After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of pancreatic secretion
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of pancreatic fistula
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dong Do You, MD, PhD, The Catholic University of Korea
Publications and helpful links
General Publications
- Bauer W, Briner U, Doepfner W, Haller R, Huguenin R, Marbach P, Petcher TJ, Pless. SMS 201-995: a very potent and selective octapeptide analogue of somatostatin with prolonged action. Life Sci. 1982 Sep 13;31(11):1133-40. doi: 10.1016/0024-3205(82)90087-x.
- Buchler M, Friess H, Klempa I, Hermanek P, Sulkowski U, Becker H, Schafmayer A, Baca I, Lorenz D, Meister R, et al. Role of octreotide in the prevention of postoperative complications following pancreatic resection. Am J Surg. 1992 Jan;163(1):125-30; discussion 130-1. doi: 10.1016/0002-9610(92)90264-r.
- Di Carlo V, Chiesa R, Pontiroli AE, Carlucci M, Staudacher C, Zerbi A, Cristallo M, Braga M, Pozza G. Pancreatoduodenectomy with occlusion of the residual stump by Neoprene injection. World J Surg. 1989 Jan-Feb;13(1):105-10; discussion 110-1. doi: 10.1007/BF01671167.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XC12MIMI0138V
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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