The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy

Stomach Neoplasm Clinical Trial

— OOZFIX  

Official title:

The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy: Single-center, Non-inferiority, Open-label Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645198
• Other study ID #: HC22DISC0039
• Status: Recruiting
• Phase: Phase 4
• Start date: October 26, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2022
• Source: Bucheon St. Mary's Hospital
• Contact: Hayemin LEE
• Phone: +82+032-340-7631
• Email: hymin[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• Oozfix
Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy
• Greenplast
Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	BucheonStMarys	Bucheon-Si

Sponsors (1)

Lead Sponsor	Collaborator
Bucheon St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of (patient who suffers from) pancreatic fistula	Ratio of patient who suffers from pancreatic fistula	Postoperative day 3