Transplantation of autologous myoblast sheet to prevent perforation after endoscopic submucosal dissection for superficial nonampullary duodenal epithelial tumor

JRCT ID: jRCT2073210094

Registered date:19/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Superficial nonampullary duodenal epithelial tumor
• Date of first enrollment: 01/04/2021
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Transplantation of autologous myoblast sheet onto serosal side after endoscopic submucosal dissection for duodenal epithelial tumor.

Outcome(s)

Primary Outcome

<Efficacy outcome measures>
Onset of peritonitis after delayed perforation within postoperative 3 days
<Safety outcome measures>
1)All adverse events during the follow-up period
2)Any defect in the clinical trial product
3)Any adverse event caused by a defect in the clinical trial product

Secondary Outcome

<Efficacy outcome measures>
1)Intraabdominal abscess during the follow-up period
2)Postoperative drainage fluid examination (amylase, bilirubin),
3)Development of epithelization or stricture on postoperative days 7 and 29,
4)Intraoperative procedural accidents
(1)Perforation requiring intraoperative surgical closure
(2)Intraoperative development of microperforation
(3)Onset of bleeding
(4)Other procedural accidents
5)Time spent on laparoscopic implantation of a skeletal-muscle-derived cell sheet,
6)Success in placement of a skeletal-muscle-derived cell sheet,
7)Body temperature on the day after ESD and postoperative days 3 and 7,
8)Peripheral white blood cell count on the day after ESD, and postoperative days 3 and 7,
9)CRP level on the day after ESD and the postoperative days 3 and 7,
10)Presence or absence of abdominal pain during the follow-up period,
11)Presence or absence of the necessity of secondary emergency surgery due to onset of peritonitis after implantation of a skeletal-muscle-derived cell sheet,
12)Presence or absence of bleeding requiring emergency care
13)Curative resection rate in the whole tumors subject to ESD
14)Endoscopic mucosal resection size
15)Evaluation of resected tumor specimen
(1)Mucosal resection size
(2)Histopathology data
16)Success or failure of refeeing and presence or absence of onset of peritonitis after delayed perforation

<Safety outcome measures>
1)Serious adverse events
2)Adverse events caused by harvesting of skeletal muscle tissues
(Adverse events with an undeniable causal relationship to harvesting of skeletal muscle tissues)
3)Changes in vital signs, complete blood count, and serum chemistry

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1)Patients with SNADET without extension to the submucosa who are eligible for ESD by consensus diagnosis among specialists in gastroenterological medicine and gastroenterological surgery
2)Patients with tumor size of at least 15 mm
3)Patients aged between 20 years and 80 years at the time of consent
4)Patients who provide written informed consent for participation in this clinical trial

Exclude criteria

1)Patients who are diagnosed as SNADET on the duodenal bulb
2)Patients with muscular degenerative disease
3)Patients with metastases to lymph nodes
4)Patients with history of upper abdominal surgery
5)Patients with hypersensitivity to Factor XIII with fibrinogen (Fibrin glue), gentamicin, amphotericin B, or human serum albumin, or with previous bovine allergy or severe metal allergy
6)Patients undergoing treatment with coagulation accelerator (snake venom), antifibrinolytic agent, or aprotinin
7)Patients with preexisting alcohol poisoning or drug dependence within 6 months before the provisional registration
8)Patients with malignancy other than SNADET within 5 years before the provisional registration
9)Patients positive for HIV-1 or HIV-22, HBV, HCV, or HTLV, patients with active infection, patients with or suspected of being infected with transmissible spongiform encephalopathy, and patients with major neurocognitive disorder
10)Patients who are pregnant or at risk of becoming pregnant
11)Patients with psychosis or psychiatric symptoms as complications and who are judged difficult to participate in the clinical trial
12)Other patients who are deemed inadequate to participate in the clinical trial at the discretion of the investigator

Related Information

• Primary Sponsor: Kanetaka Kengo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development