NCT02920567

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4.4 years

First QC Date

September 28, 2016

Last Update Submit

September 28, 2016

Conditions

Periampullary Tumors

Outcome Measures

Primary Outcomes (1)

  • Amount of pancreatic secretion

    1 day

Secondary Outcomes (1)

  • Rate of pancreatic fistula

    1 day

Study Arms (2)

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

OctreotideDRUG

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

Also known as: Treatment
octreotide
PlaceboDRUG

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

Also known as: control
Placebo

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo pancreatoduodenectomy for periampullary tumors

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Catholic University of Korea St. Vincent's Hospital

Suwon, 16247, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 6128648BACKGROUND

  • 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.

    PMID: 1733360BACKGROUND

  • 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.

    PMID: 2543144BACKGROUND

MeSH Terms

Interventions

OctreotideTherapeutics

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dong Do You, MD, PhD

    The Catholic University of Korea

    STUDY DIRECTOR

Central Study Contacts

Dong Do You, MD, PhD

CONTACT

82312498303tzanggu@catholic.ac.kr

Kwang Yeol Paik, MD, Phd

CONTACT

kpaik@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

September 28, 2016

First Posted

September 30, 2016

Study Start

January 1, 2014

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

KR(1)