Pancreatic Cystic NeoplasmsNCT07087392
Inverted-Ω Anastomosis in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy
A study testing Inverted-Ω Anastomosis in people with Pancreatic Cystic Neoplasms, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cystic Neoplasms
- What is being tested?
- Inverted-Ω Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 20 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 to 75 years old, gender not limited;
- Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
- ECOG score 0-1.
Who cannot join
- Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade > 3;
- Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
- Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
- Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;
- Patients requiring combined organ resection;
- Preoperative assessment suggested that the patient might have factors such as active ulcers and bleeding in the digestive tract;
- Pregnant and lactating women;
- Any uncertain factors that have an impact on the patient's safety or compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Zhong Wu, +86 189 8060 6518, wuzhong0057@163.com
About this study
Official title: Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis
The goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:
- Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate)
- What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？
- Conditions
- Pancreatic Cystic Neoplasms
- Being tested
- Inverted-Ω Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted-Ω AnastomosisProcedure or surgery
After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract
| Study group | Role | What they receive |
|---|---|---|
| Inverted-Ω Anastomosis | Experimental | After meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract Receives: Procedure: Inverted-Ω Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and assessment of the surgical process
The incidence of intraoperative adverse events such as conversion to open surgery rate
Measured: During operation
Operative time
Operative time
Measured: During operation
Intraoperative blood loss
Intraoperative blood loss
Measured: During operation
Postoperative complications
The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS)
Measured: From the date of surgery (Day 0) up to 90 days postoperatively
Secondary outcomes (1)
Short-term survival
Measured: From the date of surgery (Day 0) up to 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cystic NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087392
- Sponsor's protocol ID
- 2025-550
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 28 Jul 2025
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Digestive Tract Reconstruction in Laparoscopic Duodenum-Preserving Pancreatic Head Resection or Laparoscopic Central Pancreatectomy: Inverted-Ω Anastomosis
- ClinicalTrials.gov ID
- NCT07087392
- Acronym / sponsor ID
- 2025-550
- Conditions
- Pancreatic Cystic Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2028 (estimated)
- First posted
- 28 Jul 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 goal of this clinical trial is to learn if inverted-Ω anastomosis after pancreatic head resection or mid-pancreatectomy works in benign or low-grade malignant tumor. It will also learn about the safety and feasibility of inverted-Ω anastomosis. The main questions it aims to answer are:
- Does inverted-Ω anastomosis operate safely? (operative time, blood loss, transfusion and conversion rate)
- What is the incidence and severity of postoperative complications in inverted -Ω anastomosis? What advantages does it have over conventional anastomosis methods such as roux-en-y？
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inverted-Ω Anastomosis | Experimental | Procedure: Inverted-Ω AnastomosisAfter meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75 years old, gender not limited;
- Patients diagnosed with benign or low-grade malignant tumors in the head or middle section of the pancreas by CT or MRI;
- ECOG score 0-1.
Key exclusion criteria (8 listed)
- Those with severe heart, liver or kidney insufficiency, or those who are assessed as intolerant to surgery or anesthesia, or those with ASA grade > 3;
- Patients with a history of or concurrent other malignant tumors, or other serious infections or infectious diseases, or those who are unable to complete the anastomosis surgery;
- Uncontrollable concomitant diseases, including but not limited to severe coronary artery disease, COPD or asthma, uncontrollable cerebrovascular diseases, symptomatic congestive failure, unstable angina pectoris, arrhythmia, or other diseases that the researchers consider ineligible for enrollment;
- Patients who have undergone other upper abdominal surgeries and digestive tract reconstruction procedures in the past;
- Patients requiring combined organ resection;
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 |
|---|---|---|
| Inverted-Ω AnastomosisAfter meeting the inclusion and exclusion criteria, duodenum-preserving pancreatic head resection or mid-pancreatic resection will be performed, and inverted-Ω anastomosis will be carried out during the operation for the reconstruction of the digestive tract | Procedure or surgery | Inverted-Ω Anastomosis |
Primary outcome
Safety and assessment of the surgical process
Time frame: During operation
The incidence of intraoperative adverse events such as conversion to open surgery rate
Operative time
Time frame: During operation
Operative time
Intraoperative blood loss
Time frame: During operation
Intraoperative blood loss
Postoperative complications
Time frame: From the date of surgery (Day 0) up to 90 days postoperatively
The incidence and severity of postoperative complications, as defined by the International Study Group on Pancreatic Surgery (ISGPS)
1 secondary outcome
Short-term survival
Time frame: From the date of surgery (Day 0) up to 3 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inverted-Ω Anastomosis in people with Pancreatic Cystic Neoplasms, run by West China 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhong Wu (+86 189 8060 6518, wuzhong0057@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and assessment of the surgical process (time frame: During operation). The study lists 4 primary outcomes in all. 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 28 Jul 2025.