Impact Of Prophylactic Octreotide To Pancreatic Exocrine Secretion

Study Overview

Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

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.

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.

Periampullary Tumors

DRUG: Octreotide
DRUG: Placebo

XC12MIMI0138V

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-09-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-09-28
First Submitted that Met QC Criteria 2016-09-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-09-30
First Posted (ESTIMATED) 2016-09-30	Results First Posted N/A	Last Verified 2016-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

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	DRUG: Octreotide After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
PLACEBO_COMPARATOR: Placebo After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days	DRUG: Placebo After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: octreotide

After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days

DRUG: Octreotide

After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days

PLACEBO_COMPARATOR: Placebo

After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days

DRUG: Placebo

After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days

Primary Outcome Measures	Measure Description	Time Frame
Amount of pancreatic secretion		1 day

Secondary Outcome Measures	Measure Description	Time Frame
Rate of pancreatic fistula		1 day

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dong Do You, MD, PhD

Phone Number: 82312498303

Email: tzanggu@catholic.ac.kr

Study Contact Backup

Name: Kwang Yeol Paik, MD, Phd

Phone Number:

Email: kpaik@catholic.ac.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Patients who will undergo pancreatoduodenectomy for periampullary tumors

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Dong Do You, MD, PhD, The Catholic University of Korea

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record