Ampullary CarcinomaNCT07744087
Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
A study testing Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy and Conventional Laparoscopic Pancreaticoduodenectomy in people with Ampullary Carcinoma and Duodenal Adenocarcinoma, run by Nanfang Hospital, Southern Medical University at 4 sites in China.
Trial summary
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ampullary Carcinoma, Duodenal Adenocarcinoma, Distal Cholangiocarcinoma
- What is being tested?
- Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy and Conventional Laparoscopic Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 4 sitesChina
- Study dates
- 4 Jun 2026to Dec 2029
- 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 years or older and younger than 75 years.
- Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
- Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
- Able to understand and comply with study procedures.
- Able and willing to provide written informed consent before any study-specific screening procedure.
- Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.
Who cannot join
- Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
- Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
- Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
- Concurrent malignancy other than the target cancer.
- Pregnancy or breastfeeding.
- Severe psychiatric disorder that would interfere with study participation.
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- Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.
- Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.
- Body mass index greater than 35 kg/m².
- Participation in another clinical trial within the previous 3 months.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Yunqiang Cai, +86 18980605029, yunqiangcaiwch@163.com
- Recruiting
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality
Tang, +86 13594016196, ttyichen@tmmu.edu.cn
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Qifan Zhang, +86 13632101860, gdwkzqf@126.com
- Recruiting
The People's Hospital of Jianyang City
Jiancheng, Sichuan, 641400
Zhang, 028-27237840, 1181843002@qq.com
About this study
Official title: Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
- Being tested
- Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy, Conventional Laparoscopic Pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Single Incision plus one-port Laparoscopic PancreaticoduodenectomyProcedure or surgery
Also called mSILPD+1
A pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol.
Conventional Laparoscopic PancreaticoduodenectomyProcedure or surgery
A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.
| Study group | Role | What they receive |
|---|---|---|
| Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy | Experimental | Not described Receives: Procedure: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy |
| Conventional Five-Port Laparoscopic Pancreaticoduodenectomy | Active comparator | Patients undergo conventional five-port laparoscopic pancreaticoduodenectomy. Standard laparoscopic technique with five abdominal trocars is adopted for pancreaticoduodenectomy and digestive tract reconstruction. Receives: Procedure: Conventional Laparoscopic Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Rate at 1 Year After Surgery
Measured: From the date of surgery to 1 year after surgery
All-Cause Mortality Within 90 Days After Surgery
Measured: From surgery through 90 days after surgery
Secondary outcomes (6)
Overall Postoperative Complication Rate Within 30 Days
Measured: From surgery through 30 days after surgery
R0 Resection Rate
R0 resection rate, defined as the percentage of subjects without microscopic residual tumor on surgical margins based on final postoperative pathological assessment.
Measured: At final postoperative pathological assessment, up to 30 days after surgery
Operative Time
Measured: During the index surgery
Disease-Free Survival Rate at 1 Year After Surgery
Measured: From the date of surgery to 1 year after surgery
Conversion to Open Surgery Rate
Measured: During the index surgery
Postoperative Length of Hospital Stay
Duration of hospitalization from the date of surgery until hospital discharge, reported as number of days.
Measured: From surgery to hospital discharge, up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start4 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ampullary CarcinomaStudies 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
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744087
- Sponsor's protocol ID
- NFEC-2026-403
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07744087
- Acronym / sponsor ID
- NFEC-2026-403
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy | Experimental | Procedure: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy |
| Conventional Five-Port Laparoscopic Pancreaticoduodenectomy | Active comparator | Procedure: Conventional Laparoscopic PancreaticoduodenectomyPatients undergo conventional five-port laparoscopic pancreaticoduodenectomy. Standard laparoscopic technique with five abdominal trocars is adopted for pancreaticoduodenectomy and digestive tract reconstruction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older and younger than 75 years.
- Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
- Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
- Able to understand and comply with study procedures.
- Able and willing to provide written informed consent before any study-specific screening procedure.
Key exclusion criteria (10 listed)
- Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
- Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
- Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
- Concurrent malignancy other than the target cancer.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Modified Single Incision plus one-port Laparoscopic PancreaticoduodenectomyAlso: mSILPD+1A pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol. | Procedure or surgery | Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy |
| Conventional Laparoscopic PancreaticoduodenectomyA conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol. | Procedure or surgery | Conventional Five-Port Laparoscopic Pancreaticoduodenectomy |
Primary outcome
Overall Survival Rate at 1 Year After Surgery
Time frame: From the date of surgery to 1 year after surgery
All-Cause Mortality Within 90 Days After Surgery
Time frame: From surgery through 90 days after surgery
6 secondary outcomes
Overall Postoperative Complication Rate Within 30 Days
Time frame: From surgery through 30 days after surgery
R0 Resection Rate
Time frame: At final postoperative pathological assessment, up to 30 days after surgery
Operative Time
Time frame: During the index surgery
Disease-Free Survival Rate at 1 Year After Surgery
Time frame: From the date of surgery to 1 year after surgery
Conversion to Open Surgery Rate
Time frame: During the index surgery
Postoperative Length of Hospital Stay
Time frame: From surgery to hospital discharge, up to 30 days after surgery
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 4 Aug 2026.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy and Conventional Laparoscopic Pancreaticoduodenectomy in people with Ampullary Carcinoma and Duodenal Adenocarcinoma, run by Nanfang Hospital, Southern Medical University at 4 sites 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Chenfenglin Yang (+86 18583065665, 15182546920@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival Rate at 1 Year After Surgery (time frame: From the date of surgery to 1 year after surgery). The study lists 2 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 4 Aug 2026.