Trial Outcomes & Findings for Hydrogel Injection to Assist Endoscopic Submucosal Dissection (NCT NCT03321396)

Last Updated: 2019-11-27

Results Overview

To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

5 days after resection

Results posted on

2019-11-27

Participant Flow

The recruitment started in January 2017. The location was taken place at National Cheng Kung University Hospital. Patients who met the inclusion criteria were recruited.

Participant milestones

Participant milestones
Measure	Endoscopic Submucosal Dissection All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Endoscopic Submucosal Dissection All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Overall Study Physician Decision	1

Baseline Characteristics

Hydrogel Injection to Assist Endoscopic Submucosal Dissection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endoscopic Submucosal Dissection n=12 Participants All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Age, Continuous	62.5 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Taiwan	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days after resection

Outcome measures

Outcome measures
Measure	Endoscopic Submucosal Dissection n=12 Participants All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Number of Patients With Postpolypectomy Electrocoagulation Syndrome	0 Participants

SECONDARY outcome

Timeframe: An average of 4 weeks

Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.

Outcome measures

Outcome measures
Measure	Endoscopic Submucosal Dissection n=12 Participants All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Number of Patients With Delayed Bleeding/Perforation	1 Participants

SECONDARY outcome

Timeframe: One month after endoscopy

To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.

Outcome measures

Outcome measures
Measure	Endoscopic Submucosal Dissection n=12 Participants All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Number of Patients With Late Tissue Injury	0 Participants

Adverse Events

Endoscopic Submucosal Dissection

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Endoscopic Submucosal Dissection n=12 participants at risk All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
Gastrointestinal disorders Intraprocedural perforation	8.3% 1/12 • Number of events 1 • Through study completion, an average of 6 weeks. No adverse events occurred, such as fever, severe abdominal pain and delay-bleeding.
Gastrointestinal disorders Intraprocedural bleeding	8.3% 1/12 • Number of events 1 • Through study completion, an average of 6 weeks. No adverse events occurred, such as fever, severe abdominal pain and delay-bleeding.

Additional Information

Dr. Xi-Zhang Lin

Department of Internal Medicine, National Cheng Kung University

Phone: 886-6-2353535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place