Clinical trial NCT04985071: Complication of Pancreatic Fistula and Bleeding After Pancreaticoduodenectomy in Treatment Periampullary Cancer
Official title: Study of Pancreatic Fistula and Bleeding Complication After Pancreaticoduodenectomy in Treatment Periampullary Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periampullary Cancer
Pancreatic Fistula
Bleeding
Keywords: Pancreatic Surgery
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with periampullary cancer will be underwent pancreaticoduodenectomy and will be followed-up after operation.

Brief summary: This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

Detailed description: The investigator will conduct this study at both site at the same time: Cho Ray Hospital and University and Pharmacy Center. The investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. The investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications.

Plan for conducting the study:

* The patient diagnosed with periampullary cancer will be consulted with surgical method, operative risks, postoperative complications and agree to participate in the study. The patient signes a consent form to participate in the study.
* Pancreaticoduodenectomy will be performed according to the uniformity protocol of both hospitals: Cho Ray Hospital and University of Medicine and Pharmacy Center.
* Post-operative data will be collected and based on the general procedure.

Data analysis

* To determine the incidence of pancreatic fistula and bleeding, survival analysis will be used.
* To determine the association of risk factors with pancreatic fistula and bleeding, logistic regression was used, the value with p \< 0.05 will be included in the multivariable regression model to determine the real risk factors.

Sample size:

• The investigator expect approximately 100 patients in the first year in both centers. And the investigator hope at least 110 patients in the whole conducting time.

Plan for missing data:

• The investigator will directly collect the patient information before the operation, observe the operation process and follow-up the postoperative during. Investigator will remove any case that missing preoperative information, operative data or post-operative laboratory test.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with periampullary cancer meet the following criteria:

  * Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration.
  * The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas)

Exclusion Criteria:

* The patient has other organ's cancer beyond periampullary cancer.
* Patient's medical conditions contraindicate for anesthesia.
* The patient does not consent to participate in the study

Primary outcomes:
measure: Pancreatic fistula
timeFrame: 90 post-operative days
Secondary outcomes:
measure: Bleeding complication
timeFrame: 90 post-operative days
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Phan Minh Tri
Study officials:
affiliation: University of Medicine and Pharmacy at HoChiMinh City
name: TruongQuoc Vo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.