Impact of Prophylactic Octreotide to Pancreatic Exocrine... | NCT02920567

Studies
Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

NCT02920567

Sponsor

Saint Vincent's Hospital, Korea

Status

Unknown status

Last Update Posted

Sep 30, 2016Estimated

Enrollment

282Estimated

Phase

Not Applicable

Conditions

Periampullary Tumors

Interventions

Octreotide
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Sep 28, 2016

First Posted Date

Sep 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2016

Last Update Posted Date

Sep 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

YOU DONG DO, Associated Professor, Saint Vincent's Hospital, KoreaPrincipal Investigator

Lead Sponsor

Saint Vincent's Hospital, KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

282Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
octreotide	Experimental	After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days	Drug: Octreotide
Placebo	Placebo Comparator	After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Octreotide	Drug	After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days	octreotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of pancreatic secretion		1 day

Secondary Outcomes

Measure	Description	Time Frame
Rate of pancreatic fistula		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Do You, MD, PhD	Contact	82312498303		tzanggu@catholic.ac.kr
Kwang Yeol Paik, MD, Phd	Contact			kpaik@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
Dong Do You, MD, PhD	The Catholic University of Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Catholic University of Korea St. Vincent's Hospital	Recruiting	Suwon		16247	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6128648	Background	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.
1733360	Background	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.

Type	Date	Date Unknown
Release	Apr 22, 2019
Reset	Jul 12, 2019

ID	Term
D015282	Octreotide
D013812	Therapeutics

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides