ClinicalTrials.gg
Status unknownNCT03398941Updated Jan 16, 2018

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

An interventional study of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide in Pancreatic Diseases, sponsored by Chengfeng Wang. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-16.

Sponsored by Chengfeng Wang · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 23 studies in Pancreatic Diseases with a site in China — 15 open to participants now, 15 under way, none of them phase 3. Pancreatic Diseases · China.

Planned enrollment
13th of 18
150 · median 200
Started
2018
the only one that year
No phase
16 of 23
11 open now
Registered
5th of 23
by date
Lead sponsor
1 of 23
Chengfeng Wang

Among the 23 studies in Pancreatic Diseases with a site in China, this one is the 13th largest by planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2018, is one of 16 with no phase, and was the 5th registered.

Pancreatic Diseases

184 studies on the registry are indexed under Pancreatic Diseases; 63 are open to participants now.

Browse Pancreatic Diseases studies →

Open to participants now

15 of the 23 studies in Pancreatic Diseases with a site in China are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 43 Pancreatic Diseases studies recruiting now, 25 (58%) set no upper age limit and 4 (9%) stop at 75 or younger; 7 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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

Read the detailed description

The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.

Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 70 participants to take part in the trail.

The investigators can recruit about 150 participants according to previous experiences.

Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P \< 0.05.

03

Conditions studied

  • Pancreatic Diseases

Keywords

  • Pancreatic fistula
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pancreatectomy patients

Exclusion criteria

Exclusion Criteria:

  • Treated by chemotherapy or radiotherapy before With distant organ Cannot tolerate surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Combined group

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

Interventions

  • DrugPreoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide

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

06

What researchers measure

Primary outcomes

  1. pancreatic fistula

    Time frame: three week after operation

  2. delayed gastric emptying

    Time frame: three week after operation

  3. intra-abdominal fluid collections

    Time frame: three week after operation

  4. wound infection

    Time frame: three week after operation

  5. Bile leak

    Time frame: three week after operation

  6. Abdominal bleeding

    Time frame: three week after operation

07

Study locations

1 of 1 sites recruiting
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2018; primary completion for Jan 2019, 11 months later.

Of 32 interventional studies with no phase under Pancreatic Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 44. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2018
First posted
Jan 16, 2018
StartEst.
Feb 1, 2018
Primary completionEst.
Jan 1, 2019
CompletionEst.
May 1, 2019
Last update
Jan 16, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03398941
Lead sponsor
Chengfeng Wang
Responsible party
Chengfeng Wang (Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Sponsor-investigator
First posted
Jan 16, 2018
Start date
Feb 1, 2018 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
May 1, 2019 (estimated)
Last update
Jan 16, 2018

Study contacts

Chen yingtai, PhD
Contact
yingtai.chen@hotmail.com
+8618600258827
Zhao Yajie, PhD
Contact
zhaoyajielancet@qq.com
+8617319303256
Wang Chengfeng, MD
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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