Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

NCT02474914 | Completed

• 1 other identifier: Octreotide PD
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periampullary Carcinoma Resectable

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Delayed gastric emptying

  30 days

• duration of the hospital length of stay

  30 days

Study Arms (2)

Octreotide

ACTIVE COMPARATOR

Enrolled patients will be randomized to either the octreotide (sandostatin ) 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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .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.

Drug: Octreotide

Placebo

PLACEBO COMPARATOR

pancreaticoduodenectomy without octreotide postoperative

Drug: Placebo

Interventions

Octreotide DRUG

Octreotide will be given after PD

Also known as: sandostatin

Octreotide

Placebo DRUG

Octreotide will NOT be given after PD

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial.
• patients with non dilated pancreatic duct and soft pancreas

You may not qualify if:

• Age over 70.
• Patients who underwent total or distal pancreatic resection.
• Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours.
• Patients underwent neoadjuvant chemotherapy or radiotherapy.
• PD more than 3mm.
• firm pancreas.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ayman El Nakeeb

Al Mansurah, Mansoura, 356111, Egypt

Location

Related Publications (7)

• 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. doi: 10.1097/00000658-199711000-00008.

  PMID: 9389397 BACKGROUND

• 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 center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.

  PMID: 23494109 RESULT

• 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.

  PMID: 25937757 RESULT

• 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. doi: 10.1007/s00595-013-0662-x. Epub 2013 Jul 11.

  PMID: 23842691 RESULT

• Fernandez-Cruz L, Jimenez Chavarria E, Taura 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. HPB (Oxford). 2013 May;15(5):392-9. doi: 10.1111/j.1477-2574.2012.00608.x. Epub 2012 Nov 19.

  PMID: 23557411 RESULT

• 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-controlled trial. Ann Surg. 2000 Sep;232(3):419-29. doi: 10.1097/00000658-200009000-00014.

  PMID: 10973392 RESULT

• 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 clinical trial. Surgery. 1995 Jan;117(1):26-31. doi: 10.1016/s0039-6060(05)80225-9.

  PMID: 7809832 RESULT

MeSH Terms

Interventions

Octreotide; Saline Solution

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ayman El Nakeeb, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology surgical center, mansoura university

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: June 18, 2015
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2014-06

Locations

EG (1)