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

NCT03349424 | Completed Phase 4 DMC

• 1 other identifier: MS200115_0006
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Fistula

Keywords

Somatostatin; Pancreatic Fistula; Intermediate Risk; Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stilamin group

EXPERIMENTAL

Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin in addition to postoperative conventional treatment.

Drug: Somatostatin

Control group

NO INTERVENTION

Patients in the control group will receive the postoperative conventional treatment, without addition of any new medicines.

Interventions

Somatostatin DRUG

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.

Also known as: Stilamin

Stilamin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 year
• Patients underwent pancreaticoduodenectomy
• Fistula Risk Score recommended by ISGPS is intermediate risk
• Inform consent obtained

You may not qualify if:

• Pervious pancreatic surgery history
• Received somatostatin or analogues treatment less than 5 half-life periods before surgery
• Known allergy to somatostatin or mannitol
• Woman who is pregnant, plan to be pregnant or during lactation period
• Attended other clinical trials within 30 days
• All contraindications to somatostatin (Stilamin®)
• Patients with any serious disease that investigator considers he/she should be excluded

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (5)

• 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 CM, 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.

  PMID: 28040257 BACKGROUND

• 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.

  PMID: 28464570 BACKGROUND

• 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.

  PMID: 23122535 BACKGROUND

• 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. doi: 10.1046/j.0007-1323.2001.01906.x.

  PMID: 11683740 BACKGROUND

• Cao Z, Qiu J, Guo J, Xiong G, Jiang K, Zheng S, Kuang T, Wang Y, Zhang T, Sun B, Qin R, Chen R, Miao Y, Lou W, Zhao Y. A randomised, multicentre trial of somatostatin to prevent clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy. J Gastroenterol. 2021 Oct;56(10):938-948. doi: 10.1007/s00535-021-01818-8. Epub 2021 Aug 28.

  PMID: 34453212 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Yupei Zhao, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director,Professor,Chief Physician of General Surgery Department

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: June 22, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)