Endoscopic Submucosal Dissection (ESD)NCT06828250
Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD)
A study testing intradermal needle therapy in people with Endoscopic Submucosal Dissection (ESD), run by Key Laboratory for Gastrointestinal Diseases of Gansu Province at 1 site in China.
Trial summary
The objective of this clinical trial is to explore the analgesic effect of intradermal needle therapy on patients after gastric endoscopic submucosal dissection, and evaluate the safety of intradermal needle therapy. The primary questions it aims to address are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Submucosal Dissection (ESD)
- What is being tested?
- intradermal needle therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients who signed informed consent after gastric ESD were enrolled in this study.
Who cannot join
- Patients who pulled out the needles in advance;
- Individuals with psychiatric disorders, impaired communication abilities, or difficulties in self-assessment of pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intradermal Needle Therapy for Postoperative Pain After Endoscopic Submucosal Dissection (ESD): a Prospective, Randomized Controlled Study
The objective of this clinical trial is to explore the analgesic effect of intradermal needle therapy on patients after gastric endoscopic submucosal dissection, and evaluate the safety of intradermal needle therapy.
The primary questions it aims to address are:
Read more
- What is the incidence of moderate-to-severe pain after gastric endoscopic submucosal dissection (ESD)? What is the incidence of moderate-to-severe pain after treatment with intradermal needle therapy?
- What adverse reactions do patients experience after treatment with intradermal needle therapy?
- Does intradermal needle therapy alleviate postoperative pain in patients undergoing gastric endoscopic submucosal dissection (ESD)?
Patients will:
- Postoperatively, patients were randomly assigned to a treatment group and a control group. In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days. The control group received conventional postoperative treatment.
- Researchers will record the incidence of moderate-to-severe pain within 72 hours postoperatively using the VAS pain score (no pain: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-10 points). VAS pain scores and Simplified McGill Pain Questionnaire (SF-MPQ) scores will be assessed at 1h, 6h, 12h, 24h, 48h, and 72h postoperatively. The use of analgesic medications will also be noted. Preoperative and postoperative SAS and SDS scores will be documented, along with postoperative recovery details such as length of hospital stay , and surgical complications (such as fever, bleeding, and perforation). Additionally, the safety evaluation of intradermal needle therapy will include monitoring for adverse events such as dizziness, skin irritation, skin breakage, infection, hematoma, local pain or discomfort at the puncture site, or needle breakage.
- The baseline characteristics of patients will be recorded, and factors associated with postoperative pain after gastric endoscopic submucosal dissection (ESD) (including demographic data, clinicopathological features, surgical conditions, etc.) will be analyzed.
Read the detailed description
Objective: To investigate the analgesic effect and safety of intradermal needle therapy for patients after gastric endoscopic submucosal dissection (ESD).
Methods: Patients undergoing gastric endoscopic submucosal dissection (ESD) treatment at a digestive endoscopy center in Lanzhou, Gansu Province, starting in March 2025, were selected as the subjects of this study.
- Research Design: Inclusion and exclusion criteria for patients undergoing gastric endoscopic submucosal dissection (ESD) were established for screening purposes. Selected patients signed informed consent forms. Following endoscopic submucosal dissection (ESD) , patients were randomly divided into a treatment group and a control group at a 1:1 ratio based on a random number table. The treatment group received intradermal needle therapy in addition to conventional treatment, administered uniformly by trained nursing staff. The control group received conventional treatment only. Both the anesthesiologist and the endoscopic surgeon involved in the procedure were blinded to the group allocation. However, due to the particularity of the intradermal needle therapy, it was not possible to blind the patients.
- Data collection: Patient demographic data (age, gender, height, weight, comorbidities, smoking, and drinking status), clinicopathological characteristics (location, depth, and pathological classification), and surgery-related information (duration of surgery, surgery-related complications) were collected. Additionally, the occurrence of nausea, vomiting, and abdominal distension during the trial, the location of pain, and the levels of white blood cells and C-reactive protein on the first postoperative day were recorded.
- Outcomes: The primary outcome of the clinical trial was the incidence of moderate-to-severe pain within 72 hours postoperatively. Secondary outcomes included VAS pain scores at various time points (1h, 6h, 12h, 24h, 48h, and 72h postoperatively), Simplified McGill Pain Score (SF-MPQ), use of analgesic medications, preoperative and postoperative SAS and SDS scores, postoperative recovery status (including hospital stay duration and time of first postoperative flatulence), surgical complications (such as fever, bleeding, and perforation), and safety evaluation of intradermal needle therapy (including adverse reactions such as dizziness, skin allergy, skin damage, infection, hematoma, local pain, or other discomforts at the puncture site, or needle breakage).
- Sample Size Calculation: The sample size calculation was based on the findings from a preliminary experiment, where the incidence of moderate-to-severe postoperative pain was 10% in the treatment group and 40% in the control group. This difference was used to calculate the required sample size to detect clinically significant differences between the groups using PASS.2021 software. With a type 1 error probability of 0.05 (α = 0.05), a type 2 error probability of 0.2 (β = 0.2), and a power of 0.80 for a two-sided comparison and based on the aforementioned between-group difference in the incidence of moderate-to-severe postoperative pain, we determined that 64 patients were required in each group. Accounting for a 20% lost-to-follow-up rate and a 1:1 enrollment ratio, a total sample size of 78 patients (39 in each group) was included in the study.
- Conditions
- Endoscopic Submucosal Dissection (ESD)
- Being tested
- intradermal needle therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal needle therapyDevice
In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| intradermal needle therapy | Experimental | In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days. Receives: Device: intradermal needle therapy |
| conventional treatment | No intervention | The control group received conventional postoperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of moderate-to-severe pain within 72 hours postoperatively
the VAS pain score (no pain: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-10 points).
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start15 Mar 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal Dissection (ESD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Key Laboratory for Gastrointestinal Diseases of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828250
- Sponsor's protocol ID
- INT001
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradermal Needle Therapy for Postoperative Pain After Endoscopic Submucosal Dissection (ESD): a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06828250
- Acronym / sponsor ID
- INT001
- Conditions
- Endoscopic Submucosal Dissection (ESD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Key Laboratory for Gastrointestinal Diseases of Gansu ProvinceUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to explore the analgesic effect of intradermal needle therapy on patients after gastric endoscopic submucosal dissection, and evaluate the safety of intradermal needle therapy.
The primary questions it aims to address are:
- What is the incidence of moderate-to-severe pain after gastric endoscopic submucosal dissection (ESD)? What is the incidence of moderate-to-severe pain after treatment with intradermal needle therapy?
- What adverse reactions do patients experience after treatment with intradermal needle therapy?
- Does intradermal needle therapy alleviate postoperative pain in patients undergoing gastric endoscopic submucosal dissection (ESD)?
Patients will:
- Postoperatively, patients were randomly assigned to a treatment group and a control group. In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days. The control group received conventional postoperative treatment.
- Researchers will record the incidence of moderate-to-severe pain within 72 hours postoperatively using the VAS pain score (no pain: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-10 points). VAS pain scores and Simplified McGill Pain Questionnaire (SF-MPQ) scores will be assessed at 1h, 6h, 12h, 24h, 48h, and 72h postoperatively. The use of analgesic medications will also be noted. Preoperative and postoperative SAS and SDS scores will be documented, along with postoperative recovery details such as length of hospital stay , and surgical complications (such as fever, bleeding, and perforation). Additionally, the safety evaluation of intradermal needle therapy will include monitoring for adverse events such as dizziness, skin irritation, skin breakage, infection, hematoma, local pain or discomfort at the puncture site, or needle breakage.
- The baseline characteristics of patients will be recorded, and factors associated with postoperative pain after gastric endoscopic submucosal dissection (ESD) (including demographic data, clinicopathological features, surgical conditions, etc.) will be analyzed.
Detailed description
Objective: To investigate the analgesic effect and safety of intradermal needle therapy for patients after gastric endoscopic submucosal dissection (ESD).
Methods: Patients undergoing gastric endoscopic submucosal dissection (ESD) treatment at a digestive endoscopy center in Lanzhou, Gansu Province, starting in March 2025, were selected as the subjects of this study.
- Research Design: Inclusion and exclusion criteria for patients undergoing gastric endoscopic submucosal dissection (ESD) were established for screening purposes. Selected patients signed informed consent forms. Following endoscopic submucosal dissection (ESD) , patients were randomly divided into a treatment group and a control group at a 1:1 ratio based on a random number table. The treatment group received intradermal needle therapy in addition to conventional treatment, administered uniformly by trained nursing staff. The control group received conventional treatment only. Both the anesthesiologist and the endoscopic surgeon involved in the procedure were blinded to the group allocation. However, due to the particularity of the intradermal needle therapy, it was not possible to blind the patients.
- Data collection: Patient demographic data (age, gender, height, weight, comorbidities, smoking, and drinking status), clinicopathological characteristics (location, depth, and pathological classification), and surgery-related information (duration of surgery, surgery-related complications) were collected. Additionally, the occurrence of nausea, vomiting, and abdominal distension during the trial, the location of pain, and the levels of white blood cells and C-reactive protein on the first postoperative day were recorded.
- Outcomes: The primary outcome of the clinical trial was the incidence of moderate-to-severe pain within 72 hours postoperatively. Secondary outcomes included VAS pain scores at various time points (1h, 6h, 12h, 24h, 48h, and 72h postoperatively), Simplified McGill Pain Score (SF-MPQ), use of analgesic medications, preoperative and postoperative SAS and SDS scores, postoperative recovery status (including hospital stay duration and time of first postoperative flatulence), surgical complications (such as fever, bleeding, and perforation), and safety evaluation of intradermal needle therapy (including adverse reactions such as dizziness, skin allergy, skin damage, infection, hematoma, local pain, or other discomforts at the puncture site, or needle breakage).
- Sample Size Calculation: The sample size calculation was based on the findings from a preliminary experiment, where the incidence of moderate-to-severe postoperative pain was 10% in the treatment group and 40% in the control group. This difference was used to calculate the required sample size to detect clinically significant differences between the groups using PASS.2021 software. With a type 1 error probability of 0.05 (α = 0.05), a type 2 error probability of 0.2 (β = 0.2), and a power of 0.80 for a two-sided comparison and based on the aforementioned between-group difference in the incidence of moderate-to-severe postoperative pain, we determined that 64 patients were required in each group. Accounting for a 20% lost-to-follow-up rate and a 1:1 enrollment ratio, a total sample size of 78 patients (39 in each group) was included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intradermal needle therapy | Experimental | Device: intradermal needle therapyIn addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days. |
| conventional treatment | No intervention | –The control group received conventional postoperative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who signed informed consent after gastric ESD were enrolled in this study.
Key exclusion criteria (2 listed)
- Patients who pulled out the needles in advance;
- Individuals with psychiatric disorders, impaired communication abilities, or difficulties in self-assessment of pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradermal needle therapyIn addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days. | Device | intradermal needle therapy |
Primary outcome
the incidence of moderate-to-severe pain within 72 hours postoperatively
Time frame: 72 hours postoperatively
the VAS pain score (no pain: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-10 points).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Endoscopic Submucosal Dissection (ESD)
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Not yet recruitingObservational study
Follow-up After Oncological Resection by Endoscopic Colorectal ESD (Endoscopic Submucosal Dissection)
Colorectal Neoplasms
Recruiting
Comparing Reduction With ESD- Versus APC-TORe
Obesity, Roux-en-y Anastomosis Site
Not yet recruitingObservational study
Clinical Outcomes After EMR or ESD of Colorectal Neoplasms - A Multicenter Registry
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection, Endoscopic Submucosal Dissection (ESD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradermal needle therapy in people with Endoscopic Submucosal Dissection (ESD), run by Key Laboratory for Gastrointestinal Diseases of Gansu Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of moderate-to-severe pain within 72 hours postoperatively (time frame: 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.