Somatostatin Prevent Post-operation Pancreatic Fistula in Intermediate Risk Patients After Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

A Multi-center, Randomized, Controlled Study: Somatostatin Prevent Post-operation Pancreatic Fistula (POPF) in Intermediate Risk Patients After Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349424
• Other study ID #: MS200115_0006
• Status: Completed
• Phase: Phase 4
• Start date: June 22, 2018
• Est. completion date: May 24, 2019

Study information

• Verified date: February 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the preventive effects of somatostatin on post-operation pancreatic fistula in intermediate risk patients after pancreaticoduodenectomy. Patients assigned into the treatment group will be continuous intravenous infusion with the somatostatin (Stilamin®) in addition to conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.).The pancreatic fistula incidence will be monitored within 30 days after operation.

Description:

This is a multi-center randomized, controlled clinical trial. A total of 200 patients are expected to be recruited. Each trial center recruits subjects based on the sequential principle and inspect the inclusion and exclusion criteria after PD and subjects meeting the standard are assigned randomly to the treatment group or control group. Apart from conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.), the treatment group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250μg/h for 120h (total dose of 6mg/day x 5 days=30mg), beginning within 3 hours after the operation; the control group will accept conventional treatments other than the Stilamin.

The pancreatic fistula incidence, biochemical leak incidence, morbidity and number of other complications related to the pancreatectomy, length of stay in hospital, hospitalization cost, re-admission rate and re-operation rate will be monitored within 30 days after operation. Subjects will be visited for 5 times from the start to the end of the study.

Statistical Methods:Number of patients who had pancreatic fistula after surgery will be analyzed using Chi-square test.Secondary endpoints: Continuous variates will be described as mean± SD; attempted to be analyzed using analysis of variance. Categorical variates will be described as rate; attempted to be analyzed using Chi-square test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 year

2. Patients underwent pancreaticoduodenectomy

3. Fistula Risk Score recommended by ISGPS is intermediate risk

4. Inform consent obtained

Exclusion Criteria:

1. Pervious pancreatic surgery history

2. Received somatostatin or analogues treatment less than 5 half-life periods before surgery

3. Known allergy to somatostatin or mannitol

4. Woman who is pregnant, plan to be pregnant or during lactation period

5. Attended other clinical trials within 30 days

6. All contraindications to somatostatin (Stilamin®)

7. Patients with any serious disease that investigator considers he/she should be excluded

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Drug:
• Somatostatin
Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250µg/h, beginning within 3 hours (Visit 1) after the operation and lasting for 120 hours (each subject will receive the Stilamin of 30mg in total), and other postoperative conventional treatment protocol remain unchanged.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28. Review. — View Citation

Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2. — View Citation

Gouillat C, Chipponi J, Baulieux J, Partensky C, Saric J, Gayet B. Randomized controlled multicentre trial of somatostatin infusion after pancreaticoduodenectomy. Br J Surg. 2001 Nov;88(11):1456-62. — View Citation

Study Group of Pancreatic Surgery in Chinese Society of Surgery of Chinese Medical Association; Pancreatic Disease Committee of Chinese Research Hospital Association; Editorial Board of Chinese Journal of Surgery. [A consensus statement on the diagnosis, treatment, and prevention of common complications after pancreatic surgery (2017)]. Zhonghua Wai Ke Za Zhi. 2017 May 1;55(5):328-334. doi: 10.3760/cma.j.issn.0529-5815.2017.05.003. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative pancreatic fistula	A clinically relevant postoperative pancreatic fistula is now defined as a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.	30 days after operation