Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Periampullary Carcinoma Resectable Clinical Trial

— PD  

Official title:

Efficacy of Octreotide in the Prevention of Postoperative Complications After Pancreaticodudenectomy in Patients With Soft Pancreas and Non-dilated Pancreatic Duct: A Prospective Randomized Trial"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474914
• Other study ID #: Octreotide PD
• Status: Completed
• Phase: N/A
• First received: June 13, 2015
• Last updated: August 18, 2017
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: June 2014
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most frequent complications of PD and the major contributor to postoperative morbidity The aim of this study to evaluate the effect of the perioperative octreotide use after PD for prevention of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative complications, mortality and the cost benefit relationship of the use of the perioperative octreotide.

Description:

This study will be a prospective randomized controlled trial for perioperative use of octreotide in patients after PD for pancreatic and periampullary tumours from May 2014 to April 2017 in Gastroenterology surgical center, Mansoura University, Egypt.

The primary outcome of the study is the effect of perioperative use of octreotide on the rate of development of postoperative pancreatic fistula in patients after PD for pancreatic and periampullary tumours. The secondary outcome is postoperative overall complications, mortality, duration of the hospital length of stay and cost-benefit relationship of perioperative use of octreotide.

Enrolled patients will be randomized to either the octreotide or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

Inclusion Criteria:

1. All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial.

2. patients with non dilated pancreatic duct and soft pancreas

Exclusion Criteria:

Exclusion criteria:

1. Age over 70.

2. Patients who underwent total or distal pancreatic resection.

3. Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours.

4. Patients underwent neoadjuvant chemotherapy or radiotherapy.

5. PD more than 3mm.

6. firm pancreas.

7. PJ

Related Conditions & MeSH terms

• Periampullary Carcinoma Resectable
• Postoperative Complications

Intervention

Drug:
• Octreotide
Octreotide will be given after PD
• Placebo
Octreotide will NOT be given after PD

Locations

Country	Name	City	State
Egypt	Ayman El Nakeeb	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single cen — View Citation

Fernández-Cruz L, Jiménez Chavarría E, Taurà P, Closa D, Boado MA, Ferrer J. Prospective randomized trial of the effect of octreotide on pancreatic juice output after pancreaticoduodenectomy in relation to histological diagnosis, duct size and leakage. HP — View Citation

Hashimoto D, Chikamoto A, Ohmuraya M, Hirota M, Baba H. Pancreaticodigestive anastomosis and the postoperative management strategies to prevent postoperative pancreatic fistula formation after pancreaticoduodenectomy. Surg Today. 2014 Jul;44(7):1207-13. d — View Citation

Lowy AM, Lee JE, Pisters PW, Davidson BS, Fenoglio CJ, Stanford P, Jinnah R, Evans DB. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg. 1997 Nov;226(5):632-41. Review. — View Citation

Montorsi M, Zago M, Mosca F, Capussotti L, Zotti E, Ribotta G, Fegiz G, Fissi S, Roviaro G, Peracchia A, et al. Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clin — View Citation

Penumadu P, Barreto SG, Goel M, Shrikhande SV. Pancreatoduodenectomy - preventing complications. Indian J Surg Oncol. 2015 Mar;6(1):6-15. doi: 10.1007/s13193-013-0286-z. Epub 2014 Jan 19. — View Citation

Yeo CJ, Cameron JL, Lillemoe KD, Sauter PK, Coleman J, Sohn TA, Campbell KA, Choti MA. Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of development of postoperative pancreatic fistula	POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any volume of drained fluid on or after postoperative day (POD) 3 with amylase content greater than 3 times the serum amylase activity . POPF was graded into Grade A, B, and C according to the clinical course	30 day
Secondary	Delayed gastric emptying	Delayed gastric emptying was defined as output from a nasogastric tube of greater than 500 ml per day that persisted beyond 10th POD, the failure to maintain oral intake by 14th POD, or reinsertion of a nasogastric tube. Biliary leak was defined as the presence of bile in the drainage fluid that persists to 4th POD	30 days
Secondary	duration of the hospital length of stay		30 days