NCT03398941

Brief Summary

The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical Trial

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 7, 2018

Last Update Submit

January 7, 2018

Conditions

Pancreatic Diseases

Keywords

Pancreatic fistula

Outcome Measures

Primary Outcomes (6)

  • pancreatic fistula

    three week after operation

  • delayed gastric emptying

    three week after operation

  • intra-abdominal fluid collections

    three week after operation

  • wound infection

    three week after operation

  • Bile leak

    three week after operation

  • Abdominal bleeding

    three week after operation

Study Arms (1)

Combined group

EXPERIMENTAL
Drug: Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide

Interventions

Preoperative Long Period Octreotide Combined With Postoperative Short Period OctreotideDRUG

Long-Period Octreotide 20mg one week before operation combine Short Period Octreotide 0.3mg during postoperative five days.

Combined group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatectomy patients

You may not qualify if:

  • Treated by chemotherapy or radiotherapy before With distant organ metastasis Cannot tolerate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pancreatic DiseasesPancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Wang Chengfeng, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen yingtai, PhD

CONTACT

+8618600258827yingtai.chen@hotmail.com

Zhao Yajie, PhD

CONTACT

+8617319303256zhaoyajielancet@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 16, 2018

Study Start

February 1, 2018

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)