Liver CancerPhase 3SP/GC-HCCNCT02649153
Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection
A Phase 3 study testing smoked plum and gum chewing in people with Liver Cancer, run by Guangxi Medical University at 1 site in China.
Trial summary
Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- smoked plum and gum chewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2023
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Underwent open hepatic resection
- Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
Who cannot join
- Previously underwent exploratory laparotomy
- Laparoscopic surgery
- Known Central Nervous System tumors including metastatic brain disease
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients
Trial locations and contacts
1 site in 1 country.
About this study
Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. One third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.
Read the detailed description
Hepatectomy is widely used to treat patients with hepatocellular carcinoma (HCC), even those with intermediate and advanced disease. Despite its well-demonstrated clinical safety and efficacy in many patients, it is associated with postoperative morbidity and mortality. One complication after hepatectomy is delayed resumption of gastrointestinal function, known as postoperative ileus. This can decrease patient comfort and increase morbidity and mortality, prolonging hospital stay and raising healthcare costs. While postoperative ileus usually resolves within approximately 3 days, it can last longer in some cases as a condition termed postoperative paralytic ileus. Postoperative use of opioid-based analgesics can increase incidence of postoperative ileus.
No drugs or interventions to prevent or treat postoperative ileus have been approved by the China Drug Administration or the US Food and Drug Administration. Several studies show that chewing gum, a new and simple modality, can accelerate complication-free recovery of gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological surgery. This raises the question whether postoperative smoked plum, or chewing gum can reduce risk of postoperative ileus following hepatectomy. To examine this question, we conducted a randomized controlled trial to compare incidence of postoperative ileus and length of hospital stay in HCC patients who received smoked plum, chewing gum or no intervention following hepatectomy.
- Conditions
- Liver Cancer
- Being tested
- smoked plum, gum chewing
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoked plumDrug
Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus
gum chewingDrug
Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
| Study group | Role | What they receive |
|---|---|---|
| smoked plum | Experimental | Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus. Receives: Drug: smoked plum |
| gum chewing | Active comparator | Patients will receive gum chewing (three times per day) in the first day after resection until flatus. Receives: Drug: gum chewing |
| empty control | No intervention | This group patients will not receive gum chewing or smoked plum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first peristalsis
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Le-Qun Li, MD, Principal investigator, Affiliated Tumor of Guangxi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649153
- Sponsor's protocol ID
- SP/GC-HCC
- Acronym
- SP/GC-HCC
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2016
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
You XM, Mo XS, Ma L, Zhong JH, Qin HG, Lu Z, Xiang BD, Wu FX, Zhao XH, Tang J, Pang YH, Chen J, Li LQ. Randomized Clinical Trial Comparing Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Patients With Hepatocellular Carcinoma After Hepatectomy. Medicine (Baltimore). 2015 Nov;94(45):e1968. doi: 10.1097/MD.0000000000001968.
PubMed 26559269Jang SY, Ju EY, Kim DE, Kim JH, Kim YH, Son M, Jang M, Jeong JH, Kim KS. First flatus time and xerostomia associated with gum-chewing after liver resection. J Clin Nurs. 2012 Aug;21(15-16):2188-92. doi: 10.1111/j.1365-2702.2012.04132.x. Epub 2012 Jun 2.
PubMed 22672009
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection
- ClinicalTrials.gov ID
- NCT02649153
- Acronym / sponsor ID
- SP/GC-HCC / SP/GC-HCC
- Conditions
- Liver Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. One third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.
Detailed description
Hepatectomy is widely used to treat patients with hepatocellular carcinoma (HCC), even those with intermediate and advanced disease. Despite its well-demonstrated clinical safety and efficacy in many patients, it is associated with postoperative morbidity and mortality. One complication after hepatectomy is delayed resumption of gastrointestinal function, known as postoperative ileus. This can decrease patient comfort and increase morbidity and mortality, prolonging hospital stay and raising healthcare costs. While postoperative ileus usually resolves within approximately 3 days, it can last longer in some cases as a condition termed postoperative paralytic ileus. Postoperative use of opioid-based analgesics can increase incidence of postoperative ileus.
No drugs or interventions to prevent or treat postoperative ileus have been approved by the China Drug Administration or the US Food and Drug Administration. Several studies show that chewing gum, a new and simple modality, can accelerate complication-free recovery of gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological surgery. This raises the question whether postoperative smoked plum, or chewing gum can reduce risk of postoperative ileus following hepatectomy. To examine this question, we conducted a randomized controlled trial to compare incidence of postoperative ileus and length of hospital stay in HCC patients who received smoked plum, chewing gum or no intervention following hepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| smoked plum | Experimental | Drug: smoked plumPatients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus. |
| gum chewing | Active comparator | Drug: gum chewingPatients will receive gum chewing (three times per day) in the first day after resection until flatus. |
| empty control | No intervention | –This group patients will not receive gum chewing or smoked plum. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Underwent open hepatic resection
- Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
Key exclusion criteria (7 listed)
- Previously underwent exploratory laparotomy
- Laparoscopic surgery
- Known Central Nervous System tumors including metastatic brain disease
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
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 |
|---|---|---|
| smoked plumPatients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus | Drug | smoked plum |
| gum chewingPatients will receive gum chewing (three times per day) in the first day after resection until flatus. | Drug | gum chewing |
Primary outcome
Time to first peristalsis
Time frame: 3 days
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 23 Jan 2024.
- Results publication: PubMed 26559269You XM, Mo XS, Ma L, Zhong JH, Qin HG, Lu Z, Xiang BD, Wu FX, Zhao XH, Tang J, Pang YH, Chen J, Li LQ. Randomized Clinical Trial Comparing Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Patients With Hepatocellular Carcinoma After Hepatectomy. Medicine (Baltimore). 2015 Nov;94(45):e1968. doi: 10.1097/MD.0000000000001968.
- Results publication: PubMed 22672009Jang SY, Ju EY, Kim DE, Kim JH, Kim YH, Son M, Jang M, Jeong JH, Kim KS. First flatus time and xerostomia associated with gum-chewing after liver resection. J Clin Nurs. 2012 Aug;21(15-16):2188-92. doi: 10.1111/j.1365-2702.2012.04132.x. Epub 2012 Jun 2.
- Individual participant dataSharing planned: Yes
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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.
Le-Qun Li, MD principal investigator
Affiliated Tumor of Guangxi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing smoked plum and gum chewing in people with Liver Cancer, run by Guangxi Medical University 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 2 inclusion and 7 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 23 Jan 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first peristalsis (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02649153, which also lists 2 linked publications.
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 23 Jan 2024.