Pancreatic FistulaNCT03752086
Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy
A study testing greater omentum binding and Pancreatic stump exposed without omentum binding in people with Pancreatic Fistula and Pancreatic Neoplasms, run by Tongji Hospital at 1 site in China.
Trial summary
Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Fistula, Pancreatic Neoplasms
- What is being tested?
- greater omentum binding and Pancreatic stump exposed without omentum binding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2019to Apr 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who undergo DP whether made by open or laparoscopic surgery;
- Patients age 18 to 75 years;
- Patients benefit from distal pancreatectomy according to NCCN guidelines;
- The subject understands the nature of this trial and willing to comply, and ability to provide written informed consent.
Who cannot join
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs;
- History of abdominal disease or surgery which may results in obvious omentum adhesion;
- Synchronous malignancy in other organs;
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Junfang O Zhao, MD, PhD, +8615827539076, zhaojunfang2012@hotmail.com
About this study
Official title: Intra-operative Greater Omentum Binding to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial
Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort.
Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis.
Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.
- Conditions
- Pancreatic Fistula, Pancreatic Neoplasms
- Being tested
- greater omentum binding, Pancreatic stump exposed without omentum binding
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
greater omentum bindingProcedure or surgery
Bind pancreatic stump using greater omentum after distal pancreatectomy
Pancreatic stump exposed without omentum bindingProcedure or surgery
Pancreatic stump exposed without greater omentum binding after distal pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| Greater omentum binding | Experimental | Bind greater omentum to pancreatic stump after distal pancreatectomy Receives: Procedure: greater omentum binding |
| Pancreatic stump exposed | Experimental | pancreatic stump exposed without binding greater omentum after distal pancreatectomy Receives: Procedure: Pancreatic stump exposed without omentum binding |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic fistula
Incidence of pancreatic fistula defined by ISGPF classification
Measured: 90 days
Secondary outcomes (3)
overall morbidity
Incidence of any type of postoperative morbidity after distal pancreatectomy
Measured: 90 days
mortality
Incidence of patients deceased after distal pancreatectomy within follow-up period
Measured: 90 days
major complications (Clavien-Dindo ≥III)
Incidence of major complications defined as a complication with Clavien-Dindo score ≥III
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
- Investigators
- Renyi Qin, MD, PhD, Principal investigator, Department of Biliary and Pancreatic Surgery, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752086
- Sponsor's protocol ID
- TJDBPS06
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Greater Omentum Binding to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03752086
- Acronym / sponsor ID
- TJDBPS06
- Conditions
- Pancreatic Fistula, Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 23 Nov 2018 (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.
Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort.
Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis.
Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greater omentum binding | Experimental | Procedure: greater omentum bindingBind greater omentum to pancreatic stump after distal pancreatectomy |
| Pancreatic stump exposed | Experimental | Procedure: Pancreatic stump exposed without omentum bindingpancreatic stump exposed without binding greater omentum after distal pancreatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients who undergo DP whether made by open or laparoscopic surgery;
- Patients age 18 to 75 years;
- Patients benefit from distal pancreatectomy according to NCCN guidelines;
- The subject understands the nature of this trial and willing to comply, and ability to provide written informed consent.
Key exclusion criteria (5 listed)
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs;
- History of abdominal disease or surgery which may results in obvious omentum adhesion;
- Synchronous malignancy in other organs;
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4;
- Pregnant women.
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 |
|---|---|---|
| greater omentum bindingBind pancreatic stump using greater omentum after distal pancreatectomy | Procedure or surgery | Greater omentum binding |
| Pancreatic stump exposed without omentum bindingPancreatic stump exposed without greater omentum binding after distal pancreatectomy | Procedure or surgery | Pancreatic stump exposed |
Primary outcome
pancreatic fistula
Time frame: 90 days
Incidence of pancreatic fistula defined by ISGPF classification
3 secondary outcomes
overall morbidity
Time frame: 90 days
mortality
Time frame: 90 days
major complications (Clavien-Dindo ≥III)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Renyi Qin, MD, PhD principal investigator
Department of Biliary and Pancreatic Surgery, Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing greater omentum binding and Pancreatic stump exposed without omentum binding in people with Pancreatic Fistula and Pancreatic Neoplasms, run by Tongji Hospital 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junfang Zhao (+8615827539076, zhaojunfang2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic fistula (time frame: 90 days). 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 23 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.