Clinical trial NCT03349424: Somatostatin Prevent Post-operation Pancreatic Fistula in Intermediate Risk Patients After Pancreaticoduodenectomy
Official title: A Multi-center, Randomized, Controlled Study: Somatostatin Prevent Post-operation Pancreatic Fistula (POPF) in Intermediate Risk Patients After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Fistula
Keywords: Somatostatin
Pancreatic Fistula
Intermediate Risk
Pancreaticoduodenectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of post-operative pancreatic fistula
timeFrame: 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yupei Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. doi: 10.1046/j.0007-1323.2001.01906.x.
citation: 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.