Obstructive JaundiceNCT07532759
Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice
A study testing PTCD Catheter Removal and PTCD Catheter Retention in people with Obstructive Jaundice and Pancreatic Head Cancer, run by Xu'an Wang.
Trial summary
Pancreaticoduodenectomy (PD) is a complex surgical procedure commonly performed for tumors of the pancreatic head and periampullary region. Many patients present with obstructive jaundice and undergo preoperative percutaneous transhepatic cholangial drainage (PTCD) to relieve biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Jaundice, Pancreatic Head Cancer, Periampullary Neoplasms
- What is being tested?
- PTCD Catheter Removal and PTCD Catheter Retention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Apr 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years
- Patients with pancreatic head or periampullary tumors scheduled for pancreaticoduodenectomy
- Presence of obstructive jaundice and completion of preoperative
- percutaneous transhepatic cholangial drainage (PTCD)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Able to understand the study and provide written informed consent
Who cannot join
- Presence of distant metastasis or locally unresectable disease
- Severe cardiac, renal, or pulmonary dysfunction that contraindicates surgery
- Uncontrolled infection
- Pregnancy or breastfeeding
- History of major surgery within 4 weeks prior to enrollment
- Poor compliance or inability to complete follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial
Pancreaticoduodenectomy (PD) is a complex surgical procedure commonly performed for tumors of the pancreatic head and periampullary region. Many patients present with obstructive jaundice and undergo preoperative percutaneous transhepatic cholangial drainage (PTCD) to relieve biliary obstruction. However, there is currently no consensus on whether the PTCD catheter should be removed or retained during surgery.
This multicenter, prospective randomized controlled trial aims to compare two intraoperative strategies: removal versus retention of the PTCD catheter during PD. Participants will be randomly assigned to either group. The study will evaluate whether these different approaches influence postoperative outcomes, particularly major complications such as bile leak and severe postoperative morbidity within 90 days after surgery.
Read more
In addition to complications, the study will assess recovery after surgery, including return of gastrointestinal function, length of hospital stay, and quality of recovery, as well as laboratory indicators of liver function and inflammation.
The results of this study are expected to provide evidence to guide surgical decision-making regarding PTCD management during PD and to improve patient outcomes.
Read the detailed description
This multicenter, prospective, randomized controlled trial is designed to evaluate the impact of intraoperative management of preoperative percutaneous transhepatic cholangial drainage (PTCD) catheters on postoperative outcomes in patients undergoing pancreaticoduodenectomy (PD).
Participants meeting eligibility criteria will be randomly assigned in a 1:1 ratio to either intraoperative PTCD catheter removal or retention using a centralized randomization system with stratification by study center and a concealed block design. The study follows a parallel-group design without crossover.
Perioperative management, including surgical technique, postoperative care, and complication management, will be standardized across participating centers according to predefined protocols to minimize inter-center variability. Outcome assessment will be conducted by independent evaluators blinded to treatment allocation. Data will be collected prospectively using an electronic data capture (EDC) system with built-in validation rules, audit trails, and centralized monitoring to ensure data quality and integrity.
The primary analysis will focus on estimating the effect size and corresponding confidence intervals for the predefined outcomes, rather than formal hypothesis testing, given the exploratory nature of the study. Multicenter effects will be accounted for in the analysis by incorporating study center as a stratification factor or covariate.
Participants will be followed for 90 days after surgery, during which predefined clinical outcomes and safety data will be systematically recorded. The findings of this study are intended to generate high-quality preliminary evidence to inform optimal intraoperative PTCD management strategies and support the design of future confirmatory trials.
- Conditions
- Obstructive Jaundice, Pancreatic Head Cancer, Periampullary Neoplasms, Biliary Tract Neoplasms
- Being tested
- PTCD Catheter Removal, PTCD Catheter Retention
- Keywords
- Pancreaticoduodenectomy, PTCD, Biliary drainage, Biliary complications, Bile leak, Enhanced recovery, Randomized controlled trial
- Medical subject headings
- Jaundice, Obstructive, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTCD Catheter RemovalProcedure or surgery
The preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is removed intraoperatively during pancreaticoduodenectomy. Removal is performed after completion of the biliary-enteric anastomosis, followed by closure of the hepatic duct puncture site. No external biliary drainage is maintained postoperatively, and only standard abdominal drainage is used.
PTCD Catheter RetentionProcedure or surgery
The preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is retained intraoperatively during pancreaticoduodenectomy. The catheter is used as a stent to support the biliary-enteric anastomosis and is maintained for postoperative external biliary drainage. Planned removal is performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography.
| Study group | Role | What they receive |
|---|---|---|
| PTCD Catheter Removal Group | Experimental | Participants assigned to this arm will undergo intraoperative removal of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be removed after completion of the biliary-enteric anastomosis, followed by routine closure of the hepatic duct puncture site. No external biliary drainage will be maintained postoperatively, and only standard abdominal drainage will be placed. Receives: Procedure: PTCD Catheter Removal |
| PTCD Catheter Retention Group | Experimental | Participants assigned to this arm will undergo intraoperative retention of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be maintained as a stent for the biliary-enteric anastomosis and used for postoperative external drainage. Planned catheter removal will be performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography. Receives: Procedure: PTCD Catheter Retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of major postoperative complications
Incidence of a composite endpoint defined as B/C-grade bile leak according to the International Study Group of Liver Surgery (ISGLS) criteria or Clavien-Dindo grade ≥ III complications occurring after pancreaticoduodenectomy.
Measured: Up to 90 days
Secondary outcomes (8)
B/C-grade bile leak
Incidence of B/C-grade bile leak defined according to ISGLS criteria.
Measured: Up to 90 days
B/C-grade pancreatic fistula
Incidence of clinically relevant postoperative pancreatic fistula (grade B/C) defined by ISGPS criteria.
Measured: Up to 90 days
Postoperative infections
Incidence of postoperative infections, including intra-abdominal infection, biliary infection, pulmonary infection, and wound infection.
Measured: Up to 90 days
Time to gastrointestinal recovery
Time to first flatus and time to first oral intake after surgery.
Measured: Up to 30 days
Length of hospital stay
Total duration of hospitalization after surgery.
Measured: Perioperative
Time to initiation of adjuvant therapy
Time from surgery to initiation of postoperative adjuvant therapy.
Measured: Up to 90 days
90-day readmission rate
Proportion of patients readmitted within 90 days after surgery.
Measured: Up to 90 days
90-day mortality
All-cause mortality within 90 days after surgery.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: intraoperative removal or retention of the preoperative PTCD catheter during pancreaticoduodenectomy. Randomization will be stratified by study center using a block design to ensure balanced allocation within each center. The study follows a parallel-group design without crossover, and all participants will receive the allocated intervention during a single surgical procedure and be followed prospectively for 90 days.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu'an Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu'an Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532759
- Sponsor's protocol ID
- KY2026117
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 15 Jul 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07532759
- Acronym / sponsor ID
- KY2026117
- Conditions
- Obstructive Jaundice, Pancreatic Head Cancer, Periampullary Neoplasms, Biliary Tract Neoplasms
- Keywords
- Pancreaticoduodenectomy, PTCD, Biliary drainage, Biliary complications, Bile leak, Enhanced recovery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xu'an WangUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 16 Apr 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.
Pancreaticoduodenectomy (PD) is a complex surgical procedure commonly performed for tumors of the pancreatic head and periampullary region. Many patients present with obstructive jaundice and undergo preoperative percutaneous transhepatic cholangial drainage (PTCD) to relieve biliary obstruction. However, there is currently no consensus on whether the PTCD catheter should be removed or retained during surgery.
This multicenter, prospective randomized controlled trial aims to compare two intraoperative strategies: removal versus retention of the PTCD catheter during PD. Participants will be randomly assigned to either group. The study will evaluate whether these different approaches influence postoperative outcomes, particularly major complications such as bile leak and severe postoperative morbidity within 90 days after surgery.
In addition to complications, the study will assess recovery after surgery, including return of gastrointestinal function, length of hospital stay, and quality of recovery, as well as laboratory indicators of liver function and inflammation.
The results of this study are expected to provide evidence to guide surgical decision-making regarding PTCD management during PD and to improve patient outcomes.
Detailed description
This multicenter, prospective, randomized controlled trial is designed to evaluate the impact of intraoperative management of preoperative percutaneous transhepatic cholangial drainage (PTCD) catheters on postoperative outcomes in patients undergoing pancreaticoduodenectomy (PD).
Participants meeting eligibility criteria will be randomly assigned in a 1:1 ratio to either intraoperative PTCD catheter removal or retention using a centralized randomization system with stratification by study center and a concealed block design. The study follows a parallel-group design without crossover.
Perioperative management, including surgical technique, postoperative care, and complication management, will be standardized across participating centers according to predefined protocols to minimize inter-center variability. Outcome assessment will be conducted by independent evaluators blinded to treatment allocation. Data will be collected prospectively using an electronic data capture (EDC) system with built-in validation rules, audit trails, and centralized monitoring to ensure data quality and integrity.
The primary analysis will focus on estimating the effect size and corresponding confidence intervals for the predefined outcomes, rather than formal hypothesis testing, given the exploratory nature of the study. Multicenter effects will be accounted for in the analysis by incorporating study center as a stratification factor or covariate.
Participants will be followed for 90 days after surgery, during which predefined clinical outcomes and safety data will be systematically recorded. The findings of this study are intended to generate high-quality preliminary evidence to inform optimal intraoperative PTCD management strategies and support the design of future confirmatory trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: intraoperative removal or retention of the preoperative PTCD catheter during pancreaticoduodenectomy. Randomization will be stratified by study center using a block design to ensure balanced allocation within each center. The study follows a parallel-group design without crossover, and all participants will receive the allocated intervention during a single surgical procedure and be followed prospectively for 90 days.
| Arm | Type | Receives |
|---|---|---|
| PTCD Catheter Removal Group | Experimental | Procedure: PTCD Catheter RemovalParticipants assigned to this arm will undergo intraoperative removal of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be removed after completion of the biliary-enteric anastomosis, followed by routine closure of the hepatic duct puncture site. No external biliary drainage will be maintained postoperatively, and only standard abdominal drainage will be placed. |
| PTCD Catheter Retention Group | Experimental | Procedure: PTCD Catheter RetentionParticipants assigned to this arm will undergo intraoperative retention of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be maintained as a stent for the biliary-enteric anastomosis and used for postoperative external drainage. Planned catheter removal will be performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 85 years
- Patients with pancreatic head or periampullary tumors scheduled for pancreaticoduodenectomy
- Presence of obstructive jaundice and completion of preoperative
- percutaneous transhepatic cholangial drainage (PTCD)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key exclusion criteria (6 listed)
- Presence of distant metastasis or locally unresectable disease
- Severe cardiac, renal, or pulmonary dysfunction that contraindicates surgery
- Uncontrolled infection
- Pregnancy or breastfeeding
- History of major surgery within 4 weeks prior to enrollment
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 |
|---|---|---|
| PTCD Catheter RemovalThe preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is removed intraoperatively during pancreaticoduodenectomy. Removal is performed after completion of the biliary-enteric anastomosis, followed by closure of the hepatic duct puncture site. No external biliary drainage is maintained postoperatively, and only standard abdominal drainage is used. | Procedure or surgery | PTCD Catheter Removal Group |
| PTCD Catheter RetentionThe preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is retained intraoperatively during pancreaticoduodenectomy. The catheter is used as a stent to support the biliary-enteric anastomosis and is maintained for postoperative external biliary drainage. Planned removal is performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography. | Procedure or surgery | PTCD Catheter Retention Group |
Primary outcome
Composite rate of major postoperative complications
Time frame: Up to 90 days
Incidence of a composite endpoint defined as B/C-grade bile leak according to the International Study Group of Liver Surgery (ISGLS) criteria or Clavien-Dindo grade ≥ III complications occurring after pancreaticoduodenectomy.
8 secondary outcomes
B/C-grade bile leak
Time frame: Up to 90 days
B/C-grade pancreatic fistula
Time frame: Up to 90 days
Postoperative infections
Time frame: Up to 90 days
Time to gastrointestinal recovery
Time frame: Up to 30 days
Length of hospital stay
Time frame: Perioperative
Time to initiation of adjuvant therapy
Time frame: Up to 90 days
90-day readmission rate
Time frame: Up to 90 days
90-day mortality
Time frame: Up to 90 days
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 15 Jul 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.
Questions about this trial
What is this clinical trial studying?
A study testing PTCD Catheter Removal and PTCD Catheter Retention in people with Obstructive Jaundice and Pancreatic Head Cancer, run by Xu'an Wang.
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 7 inclusion and 6 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Xu'an Wang, Doctor (+86-15216680015, wang.xu_an@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite rate of major postoperative complications (time frame: Up to 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 15 Jul 2026.