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Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

NCT ID: NCT02920567

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Periampullary Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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octreotide

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

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Octreotide

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Treatment control

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Vincent's Hospital, Korea

OTHER

Sponsor Role lead

Responsible Party

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YOU DONG DO

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Do You, MD, PhD

Role: STUDY_DIRECTOR

The Catholic University of Korea

Locations

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the Catholic University of Korea St. Vincent's Hospital

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Do You, MD, PhD

Role: CONTACT

Phone: 82312498303

Email: [email protected]

Kwang Yeol Paik, MD, Phd

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 6128648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1733360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2543144 (View on PubMed)

Other Identifiers

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XC12MIMI0138V

Identifier Type: -

Identifier Source: org_study_id