Clinical trial NCT05645198: The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy
Official title: The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy: Single-center, Non-inferiority, Open-label Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stomach Neoplasm
Lead sponsor: Bucheon St. Mary's Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 13\~25% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 2\~30% and 1\~2%, respectively. These complications often result fatal clinical course, so localized fibrin agent has been widely used at postoperative surgical bed after radical gastrectomy.

Recently, natural origin polysaccharide-based carboxymetyl starch was approved as localized coagulative, no well-designed report was adressed in gastric cancer surgery field. This agent can formate physical barrier after application, thus can prevent microbleeding or pancreatic fistula after gastrectomy. THIS study is single-center, non-inferiority, open-label randomized trial that evaluates the effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy.

Detailed description: Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 13\~25% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 2\~30% and 1\~2%, respectively. These complications often result fatal clinical course, so localized fibrin agent has been widely used at postoperative surgical bed after radical gastrectomy.

Recently, natural origin polysaccharide-based carboxymetyl starch was approved as localized coagulative, no well-designed report was adressed in gastric cancer surgery field. This agent can formate physical barrier after application, thus can prevent microbleeding or pancreatic fistula after gastrectomy. THIS study is single-center, non-inferiority, open-label randomized trial that evaluates the effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy.

Eligibility criteria: Inclusion Criteria:

1. Gastric adenocarcinoma patient who underwent radical gastrectomy at Bucheon St. Mary's Hospital
2. Patient's Age is above 19 and less than 80
3. ECOG performance score : 0\~2

Exclusion Criteria:

1. Patient who underwent emergent gastrectomy
2. Patient who requires palliative gastrectomy due to advanced or metastatic carcinoma
3. Patient who requires operation due to other malignancy other than adenocrcinoma
4. Patient who underwent emergent gastrectomy or pancreatectomy before this study
5. Patient who underwent chemoradiation
6. Patient who took anticoagulants or with coagulopathy

Primary outcomes:
measure: Ratio of (patient who suffers from) pancreatic fistula
timeFrame: Postoperative day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon-Si
country: Korea, Republic of
facility: BucheonStMarys
Study officials:
affiliation: Bucheon St. Mary's Hospital
name: Hayemin LEE
role: STUDY_CHAIR
References:
citation: Washio M, Yamashita K, Niihara M, Hosoda K, Hiki N. Postoperative pancreatic fistula after gastrectomy for gastric cancer. Ann Gastroenterol Surg. 2020 Sep 21;4(6):618-627. doi: 10.1002/ags3.12398. eCollection 2020 Nov.